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Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an erectile dysfunction therapy. Read More
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Read More
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More
Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s India plant in December 2016. Read More