FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Apple Clearances Timing Raises Questions

[ Price : $8.95]

Attorney Bradley Thompson says an FDA announcement of the faster-than-usual clearance of two Apple products the day before a produ...

Group Seeks Removal of Black Box on Contrast Agents

[ Price : $8.95]

International Contrast Ultrasound Society petitions FDA urging it to remove boxed warnings from ultrasound contrast agents based o...

Pharmaceutical Laboratories and Consultants Warned

[ Price : $8.95]

FDA warns Pharmaceutical Laboratories and Consultants about repeat CGMP violations and other issues in its work as a contract labo...

FDA Denies Vaccine Safety Petition

[ Price : $8.95]

FDA denies a 2009 petition asking it to recall vaccines containing unsafe ingredients.

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that include ITG-Medev, Jabones Y Productos and Pharmaceutical Laboratories and C...

Finalize Patient Data Collection Guidance: PhRMA

[ Price : $8.95]

PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help ...

Immediate-Release Opioids Now Under REMS

[ Price : $8.95]

FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.

CBER Planning 16 Guidances for 2018

[ Price : $8.95]

CBER says it expects to publish 16 guidances under two categories during calendar year 2018.

Panel Meeting Docket Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a notice entitled Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeti...

FDA Clears WAT Medical Migraine Device

[ Price : $8.95]

FDA clears a WAT Medical 510(k) for its HeadaTerm for treating migraine headaches.