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With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
India’s drug pricing authority has proposed adding 12 cancer drugs to its list of essential therapies that are subject to price controls, while removing three under-utilized drugs. Read More
The European Medicines Agency wants to improve the access to its unpublished documents, but still reserves the right to refuse a request if disclosure would undermine protected information such as the purpose of an investigation or audit into a company. Read More
By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
Europe’s drug regulatory agency has revised the conflict of interest policy for its scientific committee members and experts, a move that one attorney says recognizes the reality that most knowledgeable specialists have at least some commercial involvement. Read More
An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation yesterday that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More