FDA Related News

Human Drugs

Court Rules for FDA Against Informed Consent Changes

The DC District Court rules in FDAs favor to dismiss a suit by the Center for Responsible Science that sought new warnings on informed consent documen...

Human Drugs

QuVa Pharma FDA-483 Released

FDA releases the FDA-483 with four observations issued following an inspection at the QuVa Pharma drug outsourcing facility in Temple, TX.

Human Drugs

FDA Reviewers Question Stanssoporfin Safety

FDA tells members of two advisory committees that InfaCares stannsoporfin appears to be effective in treating hyperbilirubinemia but may be associated...

Medical Devices

NPR Questions FDA OK for Opioid Withdrawal Device

National Public Radio says FDA approved Innovative Health Solutions Bridge medical device for use in opioid withdrawal based on a study that was misre...

Human Drugs

Orphan Status for Bavarian Nordic Cancer Vaccine

FDA grants Bavarian Nordic an orphan drug designation for its BN-Brachyury vaccine for treating chordoma, a rare cancer that develops along the spine.

FDA General

Bausch + Lomb Ultra Contact Lenses OKd for 7-Day Wear

FDA approves Bausch + Lombs Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear.

Human Drugs

7 Inspection Observations at Biocon Limited

Biocon says an FDA-483 issued following an inspection at its Bangalore, India, sterile drug manufacturing facility has seven observations.

Human Drugs

Fresenius Decision to Abandon Akorn Deal Based on Blatant Fraud

Fresenius says its decision last month to terminate the companys $4.7 billion merger agreement with generic drug company Akorn was based on alleged bl...

Medical Devices

FDA Approves Medtronic Brain Stimulator for Seizures

FDA approves a Medtronic PMA for its Deep Brain Stimulation therapy as adjunctive treatment for reducing the frequency of partial-onset seizures.

Appeals Court Strongly Backs Learned Intermediary

Attorney Jonah Knobler says that plaintiff attacks on the learned intermediary doctrine may be running out of steam, based on a 7th Circuit decision i...