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The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. Read More
Manufacturers of nonprescription drugs sold in Australia have until Dec. 20 to include statements on specific risks in the product labeling, according to the Therapeutic Goods Administration. Read More
The UK’s healthcare costs watchdog is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending that doctors prescribe three new generation anticoagulants rather than commonly used warfarin or aspirin. Read More
A loophole in the oversight of active pharmaceutical ingredients and an inconsistent reporting structure are just some of the challenges the U.S. Food and Drug Administration faces in improving drug quality in China, according to the agency’s top official there. Read More
The European Medicines Agency’s Committee for Advanced Therapies has clarified when drugs may be classified as advanced therapy medicinal products, including the criteria for classifying cells and tissues as engineered. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
India’s National Pharmaceutical Pricing Authority has set price controls on scores of branded generic drugs to treat diabetes and cardiovascular disorders, a decision one industry observer warns will discourage introduction of patented drugs as R&D drug companies worry that price controls may come to their sector as well. Read More
The EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Read More
Manufacturers looking to speed up drug approvals in the EU and ensure that their products are covered by payers should initiate parallel conversations with the European Medicines Agency and health technology assessment bodies early in the development process, the EMA says. Read More