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Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
San Francisco-based drugmaker Exelixis is halting research into the use of its thyroid cancer therapy Cometriq for treating prostate cancer after the drug failed a Phase III trial for that indication. Read More
Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market a generic version. Read More
Martin Avenue Pharmacy is recalling all of its unexpired sterile preparations and stopping production of sterile drugs after FDA investigators discovered contaminated products and evidence of poor quality control. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA GMPs, creating another quality headache for the Indian drugmaker. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials, and nine lots due to particulates in vials. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for GMPs and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More