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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know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples.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
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
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
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the U.S. Food and Drug Administration, saying draft guidance lacks clear criteria and examples. Read More
Industry groups questioned whether the U.S. Food and Drug Administration has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
The European Medicines Agency’s medical literature monitoring service kicked into full operation Sept. 1, allowing drugmakers to easily search for information on adverse reactions associated with their products. Read More
The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More