Industry News

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
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
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 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 18, 2018
By Pharmaceutical Technology Editors
Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
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 12, 2018
By Pharmaceutical Technology Editors
CPhI Korea to feature zone for finished dosage formulation drug products.
Jul 10, 2018
By Pharmaceutical Technology Editors
Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.
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