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.
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
Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More
Eight African nations have signed up to participate in the second European & Developing Countries Clinical Trials Partnership, with a ninth expected to follow suit soon. Read More
Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More
Manufacturers of biosimilars should take extra care in designing clinical trials and executing other steps needed to demonstrate that their products line up with reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More
Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
The European Medicines Agency has selected the first two drug candidates for inclusion in a pilot project, known as adaptive licensing, that aims to speed patient access to new treatments. Read More