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Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than 330 applications. Read More
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More
The Congressional Budget Office officially scored the Senate bill reauthorizing the FDA’s user fee agreements, saying it would add $740 million to the budget and a negligible amount to the deficit over its five-year life. Read More
The House Energy and Commerce Committee voted unanimously to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate more on the rising cost of prescription drugs, than on the fee programs at the heart of the bill. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More
The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs. Read More
CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Read More
An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Read More
The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More