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Two congressmen sent a letter to the CEO of Marathon Pharmaceuticals, calling the company’s decision to market an old drug for Duchenne muscular dystrophy for $89,000 per year as “outrageous” and “unconscionable.” 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