FDA Legislation Tracker
Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists? Please email us at [email protected] so we can add it to the tracker.
Last updated: 3 June 2015
Legislation Passed Into Law
| Legislation and Summary | Link to Text | Executive Summary | Signed Into Law |
|---|---|---|---|
| Designer Anabolic Steroid Control Act of 2014 | Link to legislation | Would ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products. | 18 December 2014 |
| Adding Ebola to the FDA Priority Review Voucher Program Act | Link to legislation | Would add the Ebola virus to a list of diseases eligible for a special priority review voucher. Also reforms the voucher to be easier to use and more valuable. | 16 December 2014 |
| Sunscreen Innovation Act | Link to legislation | Reforms FDA's regulation of pending and new sunscreen ingredients. Also makes reforms to FDA's Time-and-Extent (TEA) process. | Became law on 26 November 2014. |
| Drug Quality and Security Act | Link to legislation | Expands FDA's regulation of compounding pharmacies, and establishes new controls on the pharmaceutical supply chain. | Became law on 27 November 2013. |
| To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines. | Link to legislation | Added a recently-approved influenza vaccine to a list of those eligible for legal liability protections under the law. | Became law on 25 June 2013. |
| Animal Drug and Animal Generic Drug User Fee Reauthorization Act | Link to legislation | Establishes user fees for veterinary pharmaceutical products. | Became law on 13 June 2013 |
| Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) | Link to legislation | Authorizes FDA to grant emergency use authorization to products in advance of a pandemic | Became law on 13 March 2013 |
| FDA User Fee Corrections Act of 2012 | Link to legislation | Allowed FDA to collect generic drug user fees subject to a temporary ban. | Became law on 5 October 2012. |
| Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES ) Act of 2010 | Link to legislation | Enhanced penalties for anyone found guilty of stealing or counterfeiting medical products. | Became law on 5 October 2012. |
| Food and Drug Administration Safety and Innovation Act (FDASIA) | Link to legislation | Massive reform legislation reauthorized numerous user fee programs, created new user fee programs for biosimilars and generic drugs, and created several new regulatory pathways and programs. | Became law on 9 July 2012. |
Proposed Legislation
| Legislation and Summary | Link to Text | Executive Summary | Date Introduced |
|---|---|---|---|
| 2015 | |||
| Accelerating Innovation in Medicine Act | Link to Legislation | Would create a new reimbursement process for some medical devices by establishing an "Accelerating Innovation in Medicine" (AIM) list. Patients could pay for an otherwise ineligible device directly. | 1 June 2015 |
| Surrogate Endpoint Improvement and Utilization Act of 2015 | Link to Legislation | Component part of the 21st Century Cures Act | 21 May 2015 |
| A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes. | Link to Legislation | Similar to the already-introduced OPEN Act. Would grant additional periods of marketing exclusivity to old drugs approved for new (and rare) conditions. | 21 May 2015 |
| 21st Century Cures Act | Link to Legislation | Would create a dramatic overhaul of the way FDA regulates many healthcare products, including drugs, medical devices and clinical trials. | 19 May 2015 |
| A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding | Link to Legislation | Would permit office use compounding by 503A compounding pharmacies. | 20 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products. | Link to Legislation | Component part of the 21st Century Cures Act | 20 May 2015 |
| To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To facilitate the responsible communication of scientific and medical developments. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animals | Link to Legislation | Would require FDA to collect and release additional information regarding the use of antimicrobial drugs in food animals. | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with regard to the Reagan-Udall Foundation. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics | Link to Legislation | Component part of the 21st Century Cures Act | 19 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of health software, and for other purposes. | Link to Legislation | Would more narrowly structure the way in which FDA is able to regulate healthcare software. | 18 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes. | Link to Legislation | Would require FDA to systematically take into account the experiences and viewpoints of patients in the regulatory process. | 14 May 2015 |
| To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices | Link to Legislation | Would create a pathway through which medical devices intended for high-need populations could be reviewed more quickly for approval. | 14 May 2015 |
| Stop Tampering of Prescription Pills Act of 2015 | Link to Legislation | Would require generic opioid painkillers to have the same abuse-deterrent proprties as the drugs they reference. | 14 May 2015 |
| Safe and Affordable Drugs from Canada Act | Link to legislation | Would allow consumers to import drugs from Canadian pharmacies for personal use. Companion legislation to bill introduced in the Senate. | 1 May 2015 |
| Research for All Act | Link to Legislation | Requires FDA to ensure greater gender equity in clinical trials for drugs granted expedited approval. Also establishes an expedited pathway for drugs intended to treat one sex differently than the other in life-threatening diseases. | 29 April 2015 |
| Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act | Link to Legislation | Would exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty regarding what software will be regulated by the agency | 27 April 2015 |
| Advancing Breakthrough Devices for Patients Act | Link to Legislation | Would create a new pathway to expedite the regulatory review of "breakthrough" medical devices | 23 April 2015 |
| FDA Accountability for Public Safety Act | Link to Legislation | Would require the FDA commissioner personally approve an opioid drug if an advisory committee has recommended against its approval. | 15 April 2015 |
| Charlotte's Web Medical Access Act of 2015 | Link to Legislation | Would exclude cannabidiol from falling under the definition of marijuana in the Controlled Substances Act | 25 March 2015 |
| Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 | Link to Legislation | Would direct the GAO to investigate FDA's regulation of nonbiologic complex drugs, and whether the agency needs new regulatory authority. | 24 March 2015 |
| Compassionate Access, Research Expansion and Respect States (CARERS) Act of 2015 | Link to Legislation | Would make it easier to conduct research on marijuana's medicinal purposes. | 23 March 2015 |
| Advancing Hope Act of 2015 | Link to Legislation | Bill would make permanent FDA's rare pediatric disease priority review voucher program, and make several other changes to FDA's voucher programs. | 23 March 2015 |
| Preservation of Antibiotics for Medical Treatment Act of 2015 | Link to Legislation | Bill reserves eight classes of antibiotics from being routinely fed to animals | 23 March 2015 |
| Infection Reduction Labeling Act | Link to Legislation | Would allow solid antimicrobial copper products to be labeled with statements regarding infection reduction properties, and exempt those products from drug and device regulations. | 18 March 2015 |
| Speeding Access to Already Approved Pharmaceutical Act of 2015 | Link to Legislation | Would allow companies whose products are approved in the EU to request an expedited review process. FDA would review products in 90 days. | 18 March 2015 |
| Patient Choice Act of 2015 | Link to Legislation | Allows terminally ill patients to access 'adequately safe' drugs through a provisional approval pathway. Bill introduced in 2013 under same title. | 16 March 2015 |
| PATIENT Act of 2015 | Link to Legislation | Would give some drugs an additional 24 months of marketing exclusivity if they are reformulated to be safer, more effective or more abuse-resistant. | 13 March 2015 |
| Saving Kids from Candy-Flavored Drugs Act | Link to Legislation | Would increase penalties for marketing scheduled drugs contained within candy or fruit-flavored substances. | 12 March 2015 |
| Compassionate Access, Research Expansion and Respect States Act of 2015 | Link to Legislation | Would make it easier to research the medicinal properties of marijuana, and reschedule marijuana as a Class II substance under the Controlled Substances Act. | 10 March 2015 |
| Increasing the Safety of Prescription Drug Use Act of 2015 | Link to Legislation | Would require FDA to consider whether Naloxone should be available over-the-counter to consumers. | 3 March 2015 |
| Preventing Antibiotic Resistance Act | Link to Legislation | Would seek to restrict the use of "medically important" antibiotics. | 2 March 2015 |
| Synthetic Abuse and Labeling of Toxic Substances Act of 2015 (SALTS Act) | Link to Legislation | Would make it easier to controll substances if they are found to be intended for human consumption. | 27 February 2015 |
| Clinical Trials Modernization Act of 2015 | Link to Legislation | Would promote the use of adaptive clinical trial designs. | 25 February 2015 |
| FDA Safety Over Sequestration (FDA SOS) Act | Link to Legislation | Would exempt FDA's user fee funding from the effects of any future budget sequestration. | 25 February 2015 |
| Orphan Product Extensions Now Accelerating Cures & Treatments Act (OPEN ACT) | Link to Legislation | Would provide added marketing exclusivity for companies that work to get their drug products approved in new, rare conditions. | 13 February 2015 |
| Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act | Link to legislation | Would require some pharmaceutical companies to make more information about their compassionate use programs available to the public. | 12 February 2015 |
| Compassionate Freedom of Choice Act of 2015 | Link to Legislation | Would provide a liability shield to doctors and companies providing expanded access treatments to terminally ill patients. | 5 February 2015 |
| Vaccine Access, Certainty, and Innovation Act of 2015 | Link to Legislation | Intended to make it easier to develop, market and export vaccine products. | 5 February 2015 |
| Medical Innovation Act of 2015 | Link to Legislation | Would require large drug companies settling with the US government to help fund NIH. | 4 February 2015 |
| Improving Regulatory Transparency for New Medical Therapies Act | Link to Legislation | Would require the DEA to schedule FDA-approved drug products more quickly, and would extend marketing exclusivity to take into account the DEA review process. | 2 February 2015 |
| Clinical Trial Cancer Mission 2020 Act | Link to legislation | Requires clinical trials results to be posted to ClinicalTrials.gov regardless of trial outcome. | 28 January 2015 |
| Food Safety Act | Link to legislation | Would remove FDA's ability to regulate food products, potentially including dietary supplements. | 28 January 2015 |
| DISARM Act of 2015 | Link to legislation | Would create a new regulatory designation status--DISARM status--which would increase federal reimbursement for certain antibiotics. | 22 January 2015 |
| Combination Drug Development Incentive Act of 2015 | Link to legislation | Would explicitly make eligible combination drug products for five-year "new drug" exclusivity. | 20 January 2015 |
| Promise for Antibiotics and Therapeutics for Health (PATH) Act | Link to legislation | Would create a new pathway for antibiotic approvals in "limited populations." | 16 January 2015 |
| Link to legislation | Would make it easier for sponsors of "Research Use Only" (RUO) products to sell their products without violating federal law. | 13 January 2015 | |
| FAIR Generics Act | Link to legislation | Would establish limits on the ability of companies to enter into pay-for-delay agreements. | 12 January 2015 |
| Safe and Affordable Drugs from Canada Act | Link to legislation | Would allow consumers to import drugs from Canadian pharmacies for personal use. | 8 January 2015 |
| Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 | Link to legislation | Targets chemical analogues of banned or scheduled substances by making them illegal to import. | 6 January 2015 |
| Transnational Drug Trafficking Act of 2015 | Link to legislation | Targets manufacturers or chemicals used to manufacture scheduled substances under the Controlled Substances Act. | 6 January 2015 |
| 2014 | |||
| Counterfeit Drug Enforcement Act of 2014 | Link to legislation | Would increase penalties for counterfeiting pharmaceuticals. Gives FDA new recall authority. | 11 December 2014 |
| Dormant Therapies Act | Link to legislation | Would give drugs approved for unmet needs 15 years of marketing exclusivity. | 11 December 2014 |
| Promise for Antibiotics and Therapeutics for Health (PATH) Act | Link to legislation | Would create a new pathway for antibiotic approvals in "limited populations." | 10 December 2014 |
| Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act | Link to legislation | Would require some pharmaceutical companies to make more information about their compassionate use programs available to the public. | 8 December 2014 |
| MEDTECH Act | Link to legislation | Bill would exempt many types of software from regulation as a medical device. | 4 December 2014 |
| Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 | Link to legislation | Would provide added marketing exclusivity for companies that work to get their drug products approved in new, rare conditions. | 20 November 2014 |
| Adding Ebola to the FDA Priority Review Voucher Program Act | Link to legislation | Would add the Ebola virus to a list of diseases eligible for a special priority review voucher. Also reforms the voucher to be easier to use and more valuable. | 12 November 2014. (Became law on 16 December 2014) |
| Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 | Link to legislation | Would require the DEA to schedule FDA-approved drug products more quickly. | 18 September 2014 |
| Fair Access for Safe and Timely (FAST) Generics Act | Link to legislation | Would make it easier for generic drug companies to access copies of drugs subject to distribution restrictions by FDA. | 18 September 2014 |
| Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act of 2013 | Link to legislation | Creates new marketing exclusivity for drugs created for unmet needs. | 17 September 2014 |
| Safe and Affordable Drugs from Canada Act of 2014 | Link to legislation | Allows the personal import of drugs obtained from Canadian pharmacies | 26 June 2014 |
| Speeding Access to Already Approved Pharmaceuticals Act | Link to legislation | Would require FDA to significantly expedite the review and approval of drugs and medical devices already approved in the EU. | 19 June 2014 |
| Designer Anabolic Steroid Control Act of 2014 | Link to legislation | Would ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products. | 29 May 2014. (Became law on 18 December 2014.) |
| Compassionate Freedom of Choice Act | Link to legislation | Would allow terminally ill patients to import unapproved drugs. | 10 April 2014 |
| Strategies to Address Antimicrobial Resistance Act | Link to legislation | FDA asked to consult with Antimicrobial Resistance Office on any new antibiotics. | 10 April 2014 |
| Improving Regulatory Transparency for New Medical Therapies Act | Link to legislation | Would require the DEA to schedule FDA-approved drug products more quickly. | 26 March 2014 |
| Independent Innovator and Repurposing Act | Link to legislation | Bill would extent marketing exclusivity for some biological products. | 24 March 2014 |
| Sunscreen Innovation Act | Link to legislation | Reforms FDA's regulation of pending and new sunscreen ingredients. Also makes reforms to FDA's Time-and-Extent (TEA) process. | 13 March 2014 (Became law on 26 November 2014.) |
| Regenerative Medicine Promotion Act of 2014 | Link to legislation | Would task FDA with establishing a council to recommend regulatory improvements for regenerative medicine. | 13 March 2014 |
| Act to Ban Zohydro | Link to legislation | Would require FDA to revoke the approval of Zohydro, a hydrocodone-based painkiller. | 13 March 2014 |
| Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 | Link to legislation | Bill would exempt many types of software from regulation as a medical device. | 10 February 2014 |
| 2013 | |||
| Antibiotic Development to Advance Patient Treatment Act of 2013 | Link to legislation | Bill would permit FDA to approve antibiotics for limited populations. | 12 December 2013 |
| Protecting Consumer Access to Generic Drugs Act of 2013 | Link to legislation | Would prohibit pay-for-delay agreements by allowing FDA to cancel remaining marketing exclusivity. | 11 December 2013 |
| Healthcare Innovation and Marketplace Technologies Act | Link to legislation | Would require FDA to establish an Office of Wireless Health Technology to better regulate mobile health apps | 3 December 2013. |
| SOFTWARE Act of 2013 | Link to legislation | Bill would exempt many types of software from regulation as a medical device. | 22 October 2013 |
| Drug Quality and Security Act | Link to legislation | Expands FDA's regulation of compounding pharmacies, and establishes new controls on the pharmaceutical supply chain. | 27 September 2013. (Became law on 25 June 2013.) |
| Compounding Clarity Act of 2013 | Link to legislation | Would enhance the regulation of compounding pharmacies and impose new registration requirements. | 12 September 2013 |
| Medical Testing Availability Act of 2013 | Link to legislation | &Would make it easier for sponsors of "Research Use Only" (RUO) products to sell their products without violating federal law. | 2 August 2013 |
| Combination Drug Development Incentive Act of 2013 | Link to legislation | Would explicitly allow fixed-dose combination drugs to be eligible for five-year "new drug" exclusivity. | 2 August 2013 |
| S.A.F.E. Compounded Drugs Act of 2013 | Link to legislation | Would enhance the regulation of compounding pharmacies and impose new restrictions on their manufacture. | 2 August 2013 |
| Dietary Supplement Labeling Act of 2013 | Link to legislation | Would require supplement manufacturers to provide more information about their products to FDA, and tighten labeling regulations. | 1 August 2013 |
| FDA User Fee Protection Act | Link to legislation | Would exempt FDA from the federal budget sequester of 2013. | 31 July 2013 |
| Food and Drug Administration Safety Over Sequestration Act of 2013 | Link to legislation | Would exempt FDA from the federal budget sequester of 2013. | 18 July 2013 |
| Combating Prescription Drug Abuse Act | Link to legislation | Would establish a commission, including FDA, to combat the abuse of prescription drugs. | 10 July 2013 |
| Preventing Antibiotic Resistance Act of 2013 | Link to legislation | Would restrict the use of antibiotics in agricultural settings. | 27 June 2013 |
| Preserving Access to Orphan Drugs Act of 2013 | Link to legislation | Would exempt orphan drug products approved by FDA from fees under Obamacare. | 11 June 2013 |
| VALID Compounding Act | Link to legislation | Would establish a list of drugs not allowed to be compounded. | 23 May 2013 |
| Patient Choice Act of 2013 | Link to legislation | Allows terminally ill patients to access 'adequately safe' drugs through a provisional approval pathway | 22 May 2013 |
| Trial and Experimental Studies Transparency (TEST) Act | Link to legislation | Would require companies to submit the results of all registered trials to ClinicalTrials.gov | 16 May 2013 |
| Drug Supply Chain Security Act | Link to legislation | Companion legislation to the Drug Quality and Security Act (DQSA), which became law in November 2013. | 15 May 2013 |
| Pharmaceutical Quality, Security, and Accountability Act | Link to legislation | Precursor legislation to the Drug Quality and Security Act of 2013. Called for the establishment of a national track and trace system for pharmaceuticals. | 15 May 2013 |
| Gray Market Drug Reform and Transparency Act of 2013 | Link to legislation | Would more stringently regulate pharmaceutical wholesalers | 14 May 2013 |
| Safeguarding America's Pharmaceuticals Act of 2013 | Link to legislation | Precursor legislation to the Drug Quality and Security Act of 2013. Called for the establishment of a national track and trace system for pharmaceuticals. | 9 May 2013 |
| Antimicrobial Data Collection Act | Link to legislation | Requires further FDA study of the relationship between antibiotics prescribing and antimicrobial resistance trends. | 8 May 2013 |
| Cody Miller Initiative for Safer Prescriptions Act | Link to legislation | Would require consumer-friendly language on all drug labeling information, including package inserts. | 17 April 2013 |
| Animal Drug and Animal Generic Drug User Fee Reauthorization Act | Link to legislation | Establishes user fees for veterinary pharmaceutical products. | 20 March 2013. (Became law on 13 June 2013.) |
| Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES ) Act of 2010 | Link to legislation | Enhanced penalties for anyone found guilty of stealing or counterfeiting medical products. | 20 March 2013. (Became law on 5 October 2012.) |
| Asthma Inhalers Relief Act of 2013 | Link to legislation | Would prohibit FDA from banning remaining CFC-based inhalers. | 15 March 2013 |
| Preservation of Antibiotics for Medical Treatment Act of 2013 | Link to legislation | FDA can reject an application for an animal antibiotic if they believe its approval would put human health at risk. | 14 March 2013 |
| Delivering Antimicrobial Transparency in Animals Act of 2013 | Link to legislation | Would enhance data reporting requirements for marketers of antibiotics. | 26 February 2013 |
| Preserve Access to Affordable Generics Act | Link to legislation | Would, in general, prohibit pay-for-delay agreements | 4 February 2013 |
| To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines. | Link to legislation | Added a recently approved influenza vaccine to a list of those eligible for legal liability protections under the law. | 4 February 2013. (Became law on 25 June 2013.) |
| Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) | Link to legislation | Authorizes FDA to grant emergency use authorization to products in advance of a pandemic | 18 January 2013. (Became law on 13 March 2013.) |
| 2012 | |||
| FDA User Fee Corrections Act of 2012 | Link to legislation | Allowed FDA to collect generic drug user fees subject to a temporary ban. | 19 September 2012. (Became law on 5 October 2012.) |
| Food and Drug Administration Safety and Innovation Act (FDASIA) | Link to legislation | Massive reform legislation reauthorized numerous user fee programs, created new user fee programs for biosimilars and generic drugs, and created several new regulatory pathways and programs. | 15 May 2012. (Became law on 9 July 2012.) |
Did we miss a piece of proposed legislation? Let us know! Email us at [email protected], and we'll add a link to the legislation on this list.