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The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More
The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More
Avastin may contribute to tracheoesophageal (TE) fistula formation in patients with limited-stage small-cell lung cancer, Genentech said in a letter to healthcare professionals. Read More
The FDA has announced the availability of audio broadcasts on emerging drug safety information. The audio files, commonly known as podcasts, can be transmitted to personal computers and audio players. Read More
Federal device postmarket authorities are "far more extensive than for prescription drugs," and the FDA and CDRH are using their authorities to maintain continued device safety, Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, said. Read More
A hearing implant company sponsoring a device study failed to provide clinical investigators with information on hearing loss among participants, and the sponsor of another device clinical trial provided "misleading" assurance to participants that the investigational device had been judged safe by the FDA, according to two separate FDA warning letters posted recently to the agency's website. Read More
The medical device industry could see changes to the way the FDA collects user fees under a package of recommendations negotiated with the agency, which cleared a key legislative hurdle last week. Read More
Merck is seeking FDA approval to market its cervical cancer vaccine, Gardasil, for the prevention of vaginal and vulvar cancers, the company announced. Read More