Newsletter - August 17, 2017
Recruitment Issues with Cancer Trials Lead to Innovative Regulatory Scenarios
An article in the New York Times this week discusses something that all sponsors of cancer trials know too well; there are not enough patients in the US for clinical trials with new drugs. One out of three active clinical trials or about 6300 trials currently recruiting patients in the US are for anti-cancer drugs. Read More
FDA’s Accelerated Approval Challenged, But Is it Fair to Blame the Agency?
In JAMA this week, an article raises doubts about the safety and effectiveness of drugs approved by FDA via the accelerated approval program but a critical review shows that despite the concerns raised, the regulatory pathway does its job as intended. Drugs and biologics intended for... Read More
Recruitment Issues with Cancer Trials Lead to Innovative Regulatory Scenarios
An article in the New York Times this week discusses something that all sponsors of cancer trials know too well; there are not enough patients in the US for clinical trials with new drugs. One out of three active clinical trials or about 6300 trials currently recruiting patients in the US are for anti-cancer drugs. Read More
FDA’s Accelerated Approval Challenged, But Is it Fair to Blame the Agency?
In JAMA this week, an article raises doubts about the safety and effectiveness of drugs approved by FDA via the accelerated approval program but a critical review shows that despite the concerns raised, the regulatory pathway does its job as intended. Drugs and biologics intended for... Read More
