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    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...
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    Bill Would Make Permanent FDA's Rare Pediatric Voucher Program

    New legislation introduced this week would reauthorize the US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program, which is currently set to end after triggering a sunset clause in its authorizing statute. Background Priority review vouchers are incentives meant to catalyze the development of new therapies for historically under-served disease areas, such as rare pediatric diseases affecting fewer than 200,000 children in the US...
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    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...
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    Bill Would Give Some Reformulated Drugs Extra Protection from Generics

    New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take. Background The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015 , was introduced in the House on 13 March 2015 by Rep...
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    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    Trying to Treat or Cure a Rare Animal Disease? FDA Says it Wants to Help

    Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you. Background The money relates to a little-known regulatory designation established under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004. Under the law, animal conditions are effectively treated as rare if they meet either of two conditions: If the condition a...
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    Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients

    Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective. Background FDA's regulation of sunscreen ingredients popped up as a major issue starting in late 2013, when sunscreen manufacturers banded together to form a coalition ...
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    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

    The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices. Background The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed pat...
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    Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced. Background The effort, announced on 29 January 2014, is being led by Sens. Lamar Alexander (R-TN) and Richard Burr (R-NC), and is meant to complement similar efforts by the House Energy and Commerce ...
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    10 Proposals Worth Paying Attention to in the 21st Century Cures Act

    Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act . The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small. But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attrac...
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    BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill

    The US House of Representatives' Energy and Commerce (E&C) Committee today released a long-anticipated discussion draft of its 21st Century Cures Act , an ambitious attempt to overhaul the way the US Food and Drug Administration (FDA) regulates new healthcare products in the hopes of incentivizing the creation of new products to treat patients. The 393-page draft contains five main sections, as well as dozens of subtitles: Title I—Putting Patients First By Incorpora...