FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

OGD Four-Part Harmony MAPP

[ Price : $8.95]

The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communicatio...

Alkermes Reports Phase 2 Results for Narcolepsy Drug

[ Price : $8.95]

Alkermes announces that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime ...

MAHA Summit to Hear from Vance, Kennedy, Makary

[ Price : $8.95]

A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Ma...

Petition Urges FDA to Ease Oversight of Stem Cell Products

[ Price : $8.95]

A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therap...

FDA, USP, and Industry Convene to Boost Drug Quality

[ Price : $8.95]

FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on ...

What FDA Might Want in Chatbot Therapy for Depression

[ Price : $8.95]

Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversigh...

FDA OKs Companion Diagnostic for Endometrial Cancer Therapy

[ Price : $8.95]

FDA approves Promegas OncoMate MSI Dx Analysis System as a companion diagnostic for identifying endometrial carcinoma patients who...

FDA Unveils Plausible Mechanism Approval Pathway

[ Price : $8.95]

FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized ther...

Repeat CGMP Issues at Miers Laboratories

[ Price : $8.95]

FDA warns New Zealands Miers Laboratories about repeat CGMP violations in its manufacturing of finished drugs.

Neurocrines NMDA Modulator Fails Phase 2 in Depression

[ Price : $8.95]

Neurocrine Biosciences reports that its Phase 2 study of NBI-1070770, an investigational NMDA receptor modulator for major depress...