Pushing randomized clinical trials, FDA issues a draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.”
FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy.
Pushing randomized clinical trials, FDA issues a draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.”
FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy.
Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on how to optimize the dosage for oncology combination products.
CDER's Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote prescription drugs.
