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Australia’s Department of Health has moved the division overseeing the import and export of certain drugs from the department’s office of chemical safety to the Therapeutic Goods Administration’s office of scientific evaluation as part of a move to better align agency functions. Read More
The drug pricing authority in India is warning manufacturers, importers and marketers of certain essential drugs that they will face legal action if they don’t immediately submit monthly production and sales figures and other compliance documents, as officials try to address the scarcity of products in many parts of the country. Read More
The European Medicines Agency wants to help manufacturers take advantage of its adaptive licensing pilot program, which aims to speed patient access to new treatments via a process that authorizes products for use by targeted populations in stages. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
The incoming head of the European Commission has taken drug regulating responsibilities away from the EU’s health and consumers department and given them to the government’s enterprise and industry department, a decision that was welcomed by a European pharma trade group but criticized by consumers and some lawmakers. Read More
A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Indian regulators are reminding drug investigators seeking approval for clinical trials that they must submit information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product to existing options. Read More
The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. Read More