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FDA drug center head fired after commissioner's exit, replaced by DavisThe U.S. Food and Drug Administration's drug center sees a leadership change as acting head Tracy Beth Hoeg departs, replaced by deputy Mic...- Biocon's Bengaluru drug manufacturing facility gets 'Voluntary Action Indicated' classificationBiocon Biologics' drug substance facility in Bengaluru has been classified as Voluntary Action Indicated (VAI) by the USFDA. This classific...
- US Senator raises alarm over poor-quality drug imports from India and China, seeks tougher FDA inspectionsIn a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversig...
- Dr Vinay Prasad's FDA exit in less than 3 months linked to Sarepta gene therapy controversy? Check detailsDr. Vinay Prasad, a controversial figure and critic of the FDA, resigned from his high-ranking position at the agency after less than three...
- Understanding US FDA inspection: How investors and management can avoid heartburnWith India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...
- Sugary drinks wreck dental hygiene, doctors opine at AIIMS symposiumAll India Institute of Medical Science is organising an international symposium here on -- 'Is Sugar the New Tobacco' -- on November 11.
- No USFDA approval for SPARC's anti-Glaucoma eyedropWhile the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling of...
- USFDA's new India chief Altaf Ahmed Lal eager to 'scale Everest'Altaf Ahmed Lal says he will interact with the Indian industry and regulators to discuss preventive measures to avoid manufacturing lapses.
- Indian drug manufacturing sites face USFDA's warning delugeThe US drug regulator has issued warning letters to Indian drugmakers Promed Exports and Posh Chemicals for violation of good manufacturing...
- Ranbaxy says to take steps to protect revenue lossIndia’s largest drug company Ranbaxy said the US drug regulator’s decision to halt approval of drugs from one of its plants in India will a...
- US regulator charges Ranbaxy of falsifying data, test resultsTo address falsified data, FDA has invoked its Application Integrity Policy (AIP) against Paonta Sahib facility. Factors for successful M&A...
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