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The FDA is still working out details of a regulatory pathway for bispecific antibodies, but the agency has issued a guidance for developers that says, generally, the manufacturing processes should follow “standard monoclonal antibody development practices.” Read More
In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions. Read More
The FDA issued a warning letter to an over-the-counter (OTC) drugmaker in Gujarat, India for serious violations of current good manufacturing practices. Read More
Emergent BioSolutions CEO Robert Kramer said that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
The Government Accountability Office (GAO), in a letter to the HHS secretary, has reiterated that the agency needs to continue to prioritize its inspections backlog. Read More
The FDA said that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
The FDA sent a warning letter to Union City, Calif.-based drugmaker RPK Pharmaceuticals for mislabeling of a topical drug, saying the label for the drug did not match the description of the listed drug. Read More
The FDA appears to have picked up the pace of inspections after getting off to a slow start in January, issuing significantly more Form 483 inspection reports to manufacturers in March and continuing an upward trend from the previous month. Read More
The European Medicines Agency (EMA) has released new guidance on the use of good manufacturing practices (GMPs) in the production of biological starting materials for advanced therapy medicinal products (ATMPs). Read More
On May 1, revisions went into effect on the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Practices Guide, addressing the manufacturing of advanced therapy medicinal products (ATMPs) in addition to biological medicinal substances and products. Read More