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The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs. Read More
International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations. Read More
The National Cancer Institute opened a drug formulary as part of a public-private partnership with six pharmaceutical companies, allowing researchers to test the drugs in clinical and preclinical studies — alone or in combination with different companies’ products. Read More
The FDA delivered a Form 483 to a clinical trial director after an investigation revealed failures to monitor the study’s progress and to obtain required statements from investigators. Read More
The FDA approved Egalet’s extended-release morphine tablet, Arymo ER, for daily, around-the-clock pain treatment, with labeling describing physical properties that can deter abuse through injection. However, abuse by nasal and oral routes is still possible, the agency said. Read More
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