FDA Related News

New FDA Innovation Initiative Coming: Gottlieb

FDA commissioner Scott Gottlieb describes a multi-pronged approach to new agency efforts to promote manufacturer innovation through its medical produc...

Federal Register

Comments Sought on Drug Compounding Facility Fees

Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on Fees for Human Drug Compounding Outsou...

Federal Register

Comments Sought on Animal Drug User Fee Cover Sheet

Federal Register notice: FDA seeks comments on an information collection extension for Form FDA 3728, Animal Generic User Fee Act Cover Sheet.

Federal Register

Comments Sought in Social/Behavioral Research Data

Federal Register notice: FDA seeks comments on a new information collection on Data To Support Social and Behavioral Research as Used by the Food and ...

Human Drugs

Public Citizen Praises Drug Price Bill

Public Citizen says the Stop Price Gouging Act introduced in the Senate would do more to curb drug price increases than a plan President Trump executi...

Human Drugs

FDA Approves Adamis Epinephrine Pre-filled Syringe

FDA approves Adamis Pharmaceuticals Symjepi (epinephrine) 0.3 mg pre-filled single dose syringe for the emergency treatment of allergic reactions incl...

Human Drugs

FDA Releases Revised Field Alert Report Electronic Form

FDA releases a new version of Form FDA 3331a that serves as an automated form for field alert report submissions.

Human Drugs

Teva Recalls Schizophrenia Drug Due to Dissolution Failure

Teva Pharmaceuticals recalls one lot of paliperidone extended-release tablets, 3mg, 90 count bottles due to failing test results for dissolution.

Medical Devices

FDA Clears Hologic Body Contouring Product

FDA clears a Hologic 510(k) for the Cynosure body contouring product, SculpSure, to treat the back and inner and outer thighs.

Medical Devices

Possible Frameless Stereotaxic System Errors

FDA issues a safety communication cautioning that navigational accuracy errors can occur when healthcare providers use frameless stereotaxic navigatio...