Human Drugs
Botanical Drug Review MAPP Out
CDER issues a MAPP on the review of INDs and NDAs for botanical drug products.
Medical Devices
FDA Clears Syneron Medicals Profound Device
FDA clears Syneron Medicals Profound microneedling device for improving cellulite appearance.
Medical Devices
FDA Clears Joimax Probes
FDA clears two Joimax electrosurgical probes.
FDA General
Trump Expected to Bring Big Changes to FDA
Notwithstanding president-elect Donald Trumps failure to publish a written policy platform, objective assessments of his public statements lead us to ...
Federal Register
Rule Discourages Petitions Seeking to Delay ANDAs
Federal Register Final Rule. FDA amends certain regulations relating to citizen petitions to discourage their use to improperly delay approval of ANDA...
Federal Register
Guidance on Non-inferiority Trials
Federal Register Notice: FDA makes available a guidance on Non- Inferiority Clinical Trials to Establish Effectiveness.
FDA General
FDA Denies Petition on Probiotic Suppositories as Supplements
FDA denies a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the Dietary Supplement He...
Medical Devices
FDA Draft Guide on Ultrasonic Surgical Aspirators
FDA posts a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling recommendations to pr...
Human Drugs
Industry Seeks More Off-label Use Dissemination Freedom
Drug and device industries urge FDA to revise its off-label dissemination policies to allow needed dialogs with payers and the medical community so me...
Medical Devices
QS Violations Found in Valeant Inspection
FDAs New York District Office warns Valeant Pharmaceuticals about Quality System regulation problems in its development of specifications for and dist...
