We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The FDA is concerned that patients will have trouble complying with instructions for Purdue Pharma’s oxycodone drug Avridi, as two advisory panels prepare to discuss the effect of food intake on the abuse-deterrent opioid. Read More
NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More
FDA enforcement of drug companies’ use of off-label promotion is being made more difficult by Amarin’s successful lawsuit against the agency and by a government website, ClinicalTrials.gov, a law professor says. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. 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
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know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples.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