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  • Regulatory NewsRegulatory News

    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...
  • Regulatory NewsRegulatory News

    New Bill Would Reduce FDA Burden on Research-Use Devices

    A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)." The Medical Testing Availability Act of 2015 , sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013 ....
  • Regulatory NewsRegulatory News

    Drug Counterfeiters Could Get Life in Prison Under New Bill

    New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs. Counterfeit Bill Proposed The proposed legislation, The Counterfeit Drug Enforcement Act of 2014 , was introduced on 11 December 2014 by Rep. Steve Is...
  • Regulatory NewsRegulatory News

    Obama Signs Special Ebola Incentive Program Into Law

    President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars. The law, Adding Ebola to the FDA Priority Review Voucher Program Act , was signed into law by Obama on 16 December 2013. The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a pro...
  • Regulatory NewsRegulatory News

    Anabolic Steroid Regulation Bill Awaits President's Signature

    New legislation set to be signed into law by US President Barack Obama 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. Background The legislation, the Designer Anabolic Steroid Control Act (DASCA) of 2014, was passed by the US House of Representatives on 15 September 2014, and the US Senate on 11 December 2014. According to its spo...
  • Regulatory NewsRegulatory News

    Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

    • 12 December 2014
    Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...
  • Regulatory NewsRegulatory News

    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
  • Feature ArticlesFeature Articles

    Canada and the Orphan Drug Framework--Where Are We Now?

    Canada, one of the few developed countries without an orphan drug policy, is finally in the last stages of developing one. In the past, when queried about the lack of a policy, representatives from the country’s food and drug regulatory agency, Health Canada, stated that physicians could apply to have patients receive a non-approved orphan drug through the Special Access Programme or through clinical studies (if conducted in Canada). For manufacturers of orphan drug...
  • Regulatory NewsRegulatory News

    Legislation Seeks to Overhaul FDA's Compassionate Use Program

    New legislation introduced in the House of Representatives would makes changes to the US Food and Drug Administration's (FDA) "expanded access"—sometimes called " compassionate use "—policies in the hopes of making it easier for terminally ill patients to access potentially life-saving drugs. Background Under normal circumstances, companies seeking FDA approval for a new drug will first ask regulators for permission to begin a clinical trial using an application known a...
  • Regulatory NewsRegulatory News

    Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

    The US House has quickly passed legislation making changes to the  Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus. S.2917 , the  Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US House of Representatives by unanimous consent on 3 December 2013, just one day after the same bill was pas...
  • Regulatory NewsRegulatory News

    Ebola Voucher Bill Clears Senate, on Course to Become Law

    The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US Senate by unanimous consent on 2 December 2013. "Today the Senate took a strong step to support that mission by pass...
  • Regulatory NewsRegulatory News

    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...