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The FDA is willing to hold private meetings with sponsors of over-the-counter creams, gels and other topical medicines in order to protect trade secrets—but sponsors should understand that the meetings will eventually see the light of day, the agency says. Read More
Former FDA Commissioner Scott Gottlieb entered to applause at a D.C. press luncheon Friday, where he reflected on his leadership of the agency and stressed the importance of removing impediments to drug access by overhauling Medicare Part B. Read More
The FDA on Friday released a final interchangeability guidance that regulators hope will help speed cheaper biosimilars to patients who need them desperately. Read More
The Association for Accessible Medicines (AAM) and its Biosimilars Council is urging the FDA to scrap its proposed suffix-based naming policy for biological products because it would act as “a barrier to biosimilars access.” Read More
Cancer drug sponsors won’t have to do separate studies if they can demonstrate that the weight of evidence shows that a given drug is dangerous to developing babies, the FDA says in a final guidance document issued Thursday. Read More
Rising public anger over drug prices has put the drug supply chain on borrowed time, a leading Republican Congressman warned industry executives on Thursday. Read More