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October 30, 2019
A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.
October 25, 2019
The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.
October 21, 2019
The agency announced it has approved 1171 generic drugs in fiscal year 2019.
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
October 11, 2019
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
October 04, 2019
The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.
The tables can be used for new drug applications, biologics license applications, and supplements to these applications.
October 02, 2019
FDA and DEA warn four website operators to stop illegally selling opioids.