Regulatory Authority Actions

Jul 19, 2018
By Pharmaceutical Technology Editors
New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.
Jul 19, 2018
By Pharmaceutical Technology Editors
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Jul 19, 2018
By Pharmaceutical Technology Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 19, 2018
By Pharmaceutical Technology Editors
The agency has approved Tpoxx (tecovirimat), the first drug with an indication for the treatment of smallpox, to address the impact of a potential outbreak.
Jul 19, 2018
By Pharmaceutical Technology Editors
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
Jul 16, 2018
By Pharmaceutical Technology Editors
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Jul 12, 2018
By Pharmaceutical Technology Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 05, 2018
By Pharmaceutical Technology Editors
The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
Jul 03, 2018
By Pharmaceutical Technology Editors
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
Jul 03, 2018
By Pharmaceutical Technology Editors
The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
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