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Members of the House Energy & Commerce Committee requested the FDA to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
The FDA issued final guidance clarifying when large drug compounding facilities must register with the agency, making only a few changes to a draft version released in February. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More
Companies should pay close attention to quality system lapses at other firms and learn from them, warned Tom Cosgrove, director of the Office of Manufacturing Quality within CDER’s Office of Pharmaceutical Quality. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a public meeting on the draft document. Read More
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the U.S. Food and Drug Administration says. Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance issued Aug. 30. Read More
The U.S. Food and Drug Administration has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19. Read More