FDA Related News

Biologics

FDA Cautions 2 HIV Test Distributors

FDA cautions registrants of two Web sites promoting iCare HIV tests that the tests are not approved for sale in the U.S.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Apotex Research Private Ltd., Paramesh Banerji Life Sciences, Signature Formulations, JT...

Federal Register

Draft Guide on Drug Study Expansion Cohorts

Federal Register notice: FDA makes available a draft guidance entitled Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Developmen...

Federal Register

Workshop on Patient Perspectives Used for Clinical Trials

Federal Register notice: FDA announces a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to identify wh...

Medical Devices

Mobile App Cleared as Contraceptive Method

FDA grants de novo marketing for Natural Cycles Nordics Natural Cycles mobile medical application that can be used as a method of contraception to pre...

Medical Devices

Hologics Cynosure Unit Suspends Marketing of Vaginal Device

Hologics Cynosure division suspends marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, ...

Human Drugs

Court Denies J&J Motion Against Pfizers Biosimilar

A federal court in Pennsylvania denies a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab.

Medical Devices

7D Surgical Cranial Surgery Module Cleared

FDA clears a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery system for cranial surgery.

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...