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A clinical investigator received a Form 483 after an FDA review of clinical trial records found they lacked vital information, and that the clinical failed to notify an institutional review board of a serious adverse event. Read More
CDER and CBER published agendas of draft guidances planned for the 2017 calendar year, covering required pediatric study compliance and pediatric oncology development, recommendations for adaptive clinical trial designs, and the development of standards used in biologics submissions. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics and pharmacodynamics. Read More
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More
Sponsors pursuing approval of new drugs that demonstrate central nervous system activity should expect to perform thorough assessments of any potential for abuse, and be aware of specific NDA requirements. Read More
The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate statistical methods. Read More
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information. Read More
McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids. Read More
Srikem Laboratories, an India-based active pharmaceutical ingredient manufacturer has been hit with a Form 483 after an inspection showed a number of repeat observations. The firm failed to meet established specifications, laboratory control procedures and equipment failures. Read More
FDA investigators handed France-based drug manufacturer Merck Sharp & Dohme-Chibret Laboratories a Form 483 after an inspection revealed sterilization issues and drug batch failures were not reported on time. Read More
The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Read More
The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers. Read More