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The Government Accountability Office (GAO) has proposed that the FDA’s drug evaluation, biologics evaluation and medical device centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
The FDA has announced that it is requiring an update to the Boxed Warning for benzodiazepines to include the risks of abuse, physical dependence and withdrawal reactions associated with their use. Read More
In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More
The House voted to pass a short-term funding measure to keep the government running through Dec. 11 at fiscal 2020 funding levels for fiscal 2021, which begins Oct. 1. Read More
In a Senate hearing yesterday, Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said that “some time by November or December we will know” which of the three COVID-19 vaccine candidates now in late-stage trials — soon to be joined by a fourth — are safe and effective. Read More
In a proposed rule released yesterday, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
The House of Representatives on Monday passed three bipartisan pharma bills, all by voice votes, aimed at promoting continuous drug manufacturing, the release of drugs from the Strategic National Stockpile and extending the FDA’s authority for counterfeit products. Read More
HHS has clarified that last week’s memo from Secretary Alex Azar will in no way impact the FDA’s decisions on drugs and vaccines although former FDA officials say questions remain. Read More
Coronavir, a treatment developed by Russian company R-Pharm for mild-to-moderate COVID-19 infections, is slated to be offered in pharmacies in that country as early as this week. Read More
HHS on Sunday refuted reports that a new departmental memo will take decision-making power away from the FDA regarding the approval of COVID-19 vaccines or therapeutics. Read More
Despite industry resistance and reluctance from state legislatures, the Trump administration is gearing up to issue a final rule allowing states to import prescription drugs from Canada as part of its campaign to deliver lower drug prices. Read More