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A Vermont-based over the counter (OTC) skincare company Twincraft developed certain “written production and control procedures to include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient,” an FDA investigator found during an Aug. 18-25 inspection. Read More
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol last week issuing an Orange Notice, which warns of an “imminent threat to public safety.” Read More
With the FDA’s vaccine advisory committee scheduled to consider Pfizer’s COVID-19 vaccine on Dec. 10, the drugmaker is facing confusion and doubt regarding how many vaccines it can actually deliver once approval comes. Read More
The Biden transition team has asked Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious disease expert, to stay on in the role he has held there since 1984. Read More
The FDA has had trouble finding members for its vaccine advisory committee that will meet on Dec. 10, to consider recommending Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine candidate — surely one of the most important advisory panel meetings in the agency’s history. Read More
Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
Novo Nordisk has announced that effective Jan. 1, it will stop distributing discounted medications to community-based pharmacies of covered entity hospitals under the 340B Drug Pricing Program, joining other drugmakers who have taken similar steps to combat what they claim are duplicate discounts created under the program’s expansion to include contract pharmacies. Read More
A group of pharma industry investors is pressing several leading drugmakers to make their COVID-19 treatments and vaccines both affordable and accessible. Read More