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Medical Devices

Safety Alert Updates Risks with SynCardia Heart Device

FDA updates a 2016 safety alert to transplant surgeons and cardiologists about additional data that continue to indicate that there is a higher mortal...

Medical Devices

FDA, Ophthalmic Groups Hold Workshop on Digital Health

FDA and several ophthalmic-related medical associations announce a 10/23 workshop entitled Ophthalmic Digital Health to discuss factors to consider wh...

Human Drugs

Guide on Drug Expedited Programs

FDA makes available a guidance on Expedited Programs for Serious Conditions Drugs and Biologics.

Federal Register

FDA/SOCRA Clinical Trial Requirements Conference

Federal Register notice: FDA announces an educational conference co-sponsored with the Society of Clinical Research Associates on the agencys clinical...

Human Drugs

FDA Deploying Staff to Puerto Rico to Help Manufacturers, Residents

FDA deploys additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and dev...

Human Drugs

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/22/2017.

Federal Register

Comments Sought on Form 3674 Certifications

Federal Register notice: FDA seeks comments on a information collection extension for its Certification To Accompany Drug, Biological Product, and Dev...

Federal Register

FDA Panel to Review Pfizer Staph Vaccine Development Plan

Federal Register notice: FDA announces an 11/7 Vaccines and Related Biological Products Advisory Committee meeting to review a clinical development pl...

Human Drugs

Researchers Urge Better FDA Monitoring of Post-approval Studies

Researchers from the Dartmouth Institute for Health Policy and Clinical Practice say FDA should be doing more to ensure pharmaceutical sponsors meet p...

Human Drugs

FDA Accelerated OK for Mercks Keytruda in Gastric Cancer

FDA grants accelerated approval to Mercks Keytruda (pembrolizumab) for treating certain patients with recurrent locally advanced or metastatic gastric...