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 EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Australia’s Therapeutic Goods Administration (TGA) has set a September deadline for companies to adopt a common technical document format for OTC regulatory submissions. Read More
U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More
The European Medicines Agency will publish a guideline next year specifying how drugmakers will have to code and share medication errors with regulators. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
The UK’s National Institute for Health and Care Excellence has recommended Ferring Pharmaceuticals’ Firmagon as a cost-effective treatment for advanced hormone dependent prostate cancer in people with spinal metastases and signs or symptoms of spinal cord compression. Read More