FDA Related News

Commenters Seek Changes in Product Jurisdiction Rule

Three stakeholders raise concerns and suggest improvements to an FDA proposed rule on product jurisdiction.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Baxter (Claris Injectables Ltd.) and bB BioChem Laboratories.

Human Drugs

New OTC Drug Approval Approaches

FDA commissioner Scott Gottlieb outlines a new agency draft guidance on approaches to expanding approval of non-prescription drugs.

Federal Register

Science Board Extended for 2 Years

Federal Register notice: FDA announces the renewal of the Science Board for an additional two years.

Human Drugs

Comments Sought on Info Collection on Drug Registrations

Federal Register notice: FDA seeks comments on an information collection extension entitled Registration of Producers of Drugs and Listing of Drugs in...

Human Drugs

Trial Protocols Up Costs and Inefficiencies: Study

A Tufts Center for the Study of Drug Development Report says that protocol design changes since 2001 have increased clinical costs and inefficiencies.

Human Drugs

CGMP Violations Found at Claris Injectables

FDA warns Baxters Claris Injectables about CGMP violations in its production of finished pharmaceuticals at its India facility.

FDA Inclusion/Exclusion Criteria Workshop

FDA releases a summary of points covered at a 4/16 workshop on clinical trial inclusion and exclusion criteria.

Human Drugs

FDA Clears Vallum Nanotechnology PEEK Spinal Fusion Device

FDA clears a Vallum Corp. 510(k) to market a polyetheretherketone spinal interbody fusion device with a PEEKplus nanotextured surface created by the c...

Medical Devices

PMA Filed for Obesity Device

BAROnova files a PMA for the TransPyloric Shuttle device intended for treating obesity.