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Human Drugs

FDA Denies Oral Contraceptive Switch Petition

FDA denies a petition seeking a prescription to OTC switch of oral contraceptives.

Human Drugs

FDA Denies Par Generic Epinephrine Injection Request

FDA denies a Par petition asking it to require that applicants for generic Adrenalin injection have the same inactive ingredients in the same concentr...

Federal Register

Guide for Animal Drug In-use Stability Studies

Federal Register Notice: FDA makes available draft guidance #242 entitled In-Use Stability Studies and Associated Labeling Statements for Multiple-Dos...

Medical Devices

Violative Medical Device Ads: Why FDA Doesnt Act

FDA Webview editor Jim Dickinson analyzes CDRHs failure to exercise its statutory authority to regulate violative medical device advertising and promo...

Human Drugs

Guidance on ANDA Refuse-to-Receive Standards

FDA posts a guidance on ANDA Submissions Refuse-to-Receive Standards that is intended to assist applicants preparing to submit ANDAs and prior approv...

Human Drugs

Guide on Benefit-Risk Factors When Making Enforcement Decisions

FDA issues a guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.

FDA General

When Trump Comes to FDA

FDA Webview editor Jim Dickinson analyzes FDAs readiness for President Trump and predicts that when he turns his attention to the agency, hell likely ...

Medical Devices

FDA Notification on Device Emerging Signals

Barnes & Thornburg attorneys outline provisions in an FDA final guidance on evaluating and communicating medical device emerging signals.

Human Drugs

FDA Mulls REMS for Immediate Release Opioids: Woodcock

CDER director Janet Woodcock says FDA is considering requiring that immediate-release opioids come under the current REMS for extended-release/long-ac...

Medical Devices

FDA Expands Use of Dexcom Glucose Monitor

FDA expands the use of the Dexcom G5 mobile continuous glucose monitoring system to replace fingerstick testing for diabetes treatment decisions.