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The FDA has issued final guidance for industry on making postmarket safety submissions in electronic format to its Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER). Read More
Johnson & Johnson (J&J) subsidiary Janssen has become the second big pharma company to go after drug distributors to stop the sale of counterfeit versions of its HIV drugs. Read More
Sen. Elizabeth Warren (D-Mass.) has written to ask Health and Human Services Secretary Xavier Becerra to lower prescription drug prices using an obscure and controversial regulatory authority known as “march-in rights.” Read More
In a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) yesterday, ranking member Sen. Richard Burr (R-N.C.) characterized the funding in the FDA’s reauthorization agreements as “double the money for mediocre performance.” Read More
Sponsors are still not where they should be on meeting postmarket trial requirements and commitments, the FDA’s latest analysis shows: 24 percent of annual status reports for required or agreed upon postmarket trials were either late or unfiled in fiscal 2020. Read More
The five members are asking for disclosure regarding the price of the vaccine’s unit, advance payments, donations, liability and indemnification. Read More
The European Medicines Agency (EMA) has issued a final guidance for drug developers on the quality data needed to support applications to its Priority Medicines (PRIME) program and other unmet medical need review pathways. Read More
India is making moves to reduce its dependence on countries like China for sourcing active pharmaceutical ingredients (API) used in manufacturing regulated medicines. Read More
The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19. Read More