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The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to first seek the agency’s blessing and get qualification or prospective advice. Read More
Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
Chinese authorities are urging vaccine manufacturers to implement better adverse event reporting procedures during clinical research and to adhere to reporting timelines. Read More
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Jumping back into the biosimilar substitution debate, GPhA is saying it prefers doctors not be notified when a pharmacist substitutes a biosimilar for a name-brand biologic, and it supports legislative language that would implement that approach in states throughout the U.S. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
CDER plans to issue highly anticipated guidance in 2014 that addresses specifics about its biosimilars approval pathway and sheds some light on social media usage for pharma companies. Read More
Rep. Henry Waxman (D-Calif.), co-author of the 1984 bill that provided the regulatory pathway for generic drug approvals, will retire from the House at the end of 2014, Waxman said Jan. 30. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More