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Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
If an EU nation finds a safety issue with a drug and flags it for review, that decision will start a 60-day clock during which a drugmaker will have the opportunity to resolve all concerns about the product or face revocation or modifications to its market authorization. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More