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 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
The FDA is set to release a slew of product-specific guidances to help generic manufacturers demonstrate the bioequivalence between their proposed generic and the reference product. Read More
HHS has issued a new variation of its recently invalidated rule requiring drugmakers to offer discounts on orphan drugs sold to hospitals that serve the poor when the products are meant for non-rare conditions. Read More
Indian regulators are seeking information from six manufacturers of generic cancer drugs in preparation for setting price caps on the products, a move that one industry observer says was expected. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
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