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The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers, that laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
Indian pharmaceutical authorities have collected only $62 million, or roughly 9 percent, of the $688 million they say drugmakers owe in fines for the overcharging of drugs. Read More
Generic drugmakers submitting ANDAs that indicate impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
A new report from the Italian Medicines Agency says that 10 percent of Italian hospitals register pharmaceutical thefts, a problem that the European pharmaceutical industry hopes to end with a pan-European verification system set to go live by 2017. Read More
The European Medicines Agency has issued revised guidelines that aim to ease overly burdensome postmarket monitoring and reporting requirements under the EU’s 2010 good pharmacovigilance practices (GVP) regulations. Read More
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