FDA Related News

FDA to Study Overwarning in DTC Ads

FDA proposes a new Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads that is intended to research wheth...

Human Drugs

FDA Accepts UCB NDA for Seizure Nasal Spray

FDA accepts for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in patients who require con...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 8/21/2018.

Human Drugs

Draft Guide on Modernizing Clinical Trial Designs

FDA releases a new draft guidance that is intended to modernize clinical trial designs in oncology drug development.

Federal Register

Workshop on Human Skin Safety Testing for Topicals

Federal Register notice: FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utilit...

Human Drugs

FDA Approves Alnylams Onpattro for Nerve Disease

FDA approves an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease caused by hereditary transthyretin...

Federal Register

FDA Proposes New Drug Promotion Study on Disclosures

Federal Register notice: FDA submits to OMB a new information collection study entitled Disclosures in Professional and Consumer Prescription Drug Pro...

Human Drugs

Long-term Contraceptive Ring Approved

FDA approves a Population Council NDA for Annovera, first vaginal ring contraceptive that can be used for an entire year.

Medical Devices

Spacelabs Healthcare Recalls Anesthesia Device

Spacelabs Healthcare recalls the Arkon Anesthesia Delivery System due to the device going into a failed state, which causes the mechanical ventilation...

Medical Devices

Vyaire Medical Recalls AirLife Resuscitation Device

Vyaire Medical recalls its AirLife Resuscitation Device due to a manufacturing error.