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.
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national biopharmaceutical trade group. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
The FDA for the first time has consolidated all elements that generic manufacturers must include in their ANDAs in an effort to increase the success rate of new submissions. Read More
A European pharmaceutical trade group has blasted a decision by Italian regulators that would allow the government to pay for an off-label eye treatment, saying the decision was motivated by cost savings and could undermine EU’s regulatory authority. Read More
The European Medicines Agency is streamlining the declarations that Qualified Persons must file to assure the agency that makers of active substances are compliant with good manufacturing practices. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency said. Read More
Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency. Read More