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A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued late last month. Read More
The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. Read More
India’s Bharat Biotech plans to produce 700 million doses of its newly approved vaccine this year, the company’s managing director Krishna Ella said Monday. Read More
The World Health Organization (WHO) has granted the Pfizer/BioNTech COVID-19 vaccine an Emergency Use Listing — the first such listing by the standard-setting body since the pandemic began. Read More
Tier 1 over-the-counter monograph order requests involve adding a new ingredient or indication, while Tier 2 requests relate to lesser changes. Read More
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) appears ready to authorize AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine as soon as this week, a move that could help lighten the load on Pfizer/BioNTech vaccinations as the country scrambles to deal with a new, mutated strain of coronavirus. Read More
Santa Fe, Calif.-based over-the-counter (OTC) drugmaker Creative Essences drew a lengthy Form 483 report with eleven observations following an FDA inspection of its facility in late August and early September. Read More
The president’s controversial “most favored nation” strategy for lowering U.S. drug prices has been placed on hold by a federal judge pending an evaluation of its legality. Read More