FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Notice Corrected on 2 ANDA Withdrawals

[ Price : $8.95]

Federal Register notice: FDA corrects a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants.

Janssens Darzalex Faspro OKd for Multiple Myeloma

[ Price : $8.95]

FDA approves a Janssen Biotech BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and d...

Magellan Diagnostics Recalls Lead Tests

[ Price : $8.95]

Magellan Diagnostics recalls its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of fals...

Avanos Pays $22 Million Over Misbranded Device

[ Price : $8.95]

Avanos Medical agrees to pay more than $22 million to resolve a criminal charge relating to the companys fraudulent misbranding of...

Pfizer Pitching Booster Vaccine to FDA

[ Price : $8.95]

Pfizer says it is discussing its plans this week with FDA to seek authorization for a Covid-19 vaccine booster shot.

Orthopedic Cartilage Repair Products Workshop

[ Price : $8.95]

FDA announces an 11/12 virtual public workshop on orthopedic cartilage repair products that will discuss data and studies needed t...

Regulatory Review Period for Tevas Ajovy

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Teva Pharmaceuticals Ajovy ...

St. Jude Pays $27 Million Over Faulty Defibrillators

[ Price : $8.95]

St. Jude Medical agrees to pay $27 million to settle allegations under the False Claims Act that it knowingly sold defective heart...

FDA/CDC Squelch Pfizer Booster Vaccine Plans

[ Price : $8.95]

FDA and the CDC dismiss the immediate need for Covid-19 booster vaccines in the wake of a Pfizer announcement that the company int...

Woodcock Asks for OIG Review of Alzheimers Approval

[ Price : $8.95]

FDA acting commissioner Janet Woodcock distances herself further from the controversial approval of Biogens Alzheimers therapy Adu...