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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 handed warning letters to three drug manufacturers, citing them for GMP violations that range from data integrity deficiencies to sterility control failures. Read More
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
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More
The FDA has made great strides in conducting international inspections but still remains understaffed, according to the government’s official watchdog, during a time when the agency has begun to inspect more sites overseas than within the U.S. Read More
The FDA issued a draft and separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
The European Medicines Agency saw a 28 percent increase in the number of applications for orphan product designations in 2016 compared to the previous year. Read More
Regeneron Pharmaceuticals received a subpoena last month as part of a Department of Justice investigation into the nonprofit organizations that play a key role in reducing the sticker price of some drugs. Read More