FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Warns Brazilian Drug Maker Over Records Request

[ Price : $8.95]

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed ...

HealthPartners Neuroscience Center BIMO Issues

[ Price : $8.95]

FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations ...

3-Year New Clinical Investigation Exclusivity Guidance Explained

[ Price : $8.95]

Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

Senate Committee Postpones FDA Funding Bill Consideration

[ Price : $8.95]

Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republ...

Cingulate Gets FDA Complete Response Letter on ADHD Drug

[ Price : $8.95]

FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

[ Price : $8.95]

FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...

Repeat Medline CGMP Violations Cited

[ Price : $8.95]

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

CGMP Violations at Laboratorios Jaloma

[ Price : $8.95]

FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.

Manufacturer Economic Info Communications Q&A Guidance

[ Price : $8.95]

FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.

ICH Finalizes Guide on Model-Informed Drug Development

[ Price : $8.95]

FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...