FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Type 5 DMFs for Drug-led Combo Product Guide

[ Price : $8.95]

FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Sof...

FDA Fact Sheet on Device Consensus Standards Pilot

[ Price : $8.95]

FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.

Allergan Pays $750 Million on Namenda Switch Scheme

[ Price : $8.95]

Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Al...

Heron NDA Resubmission for Post-Op Pain Drug

[ Price : $8.95]

FDA accepts for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain...

Info Collection Extension for CLIA Categorizations

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Labo...

Melintas Baxdela Expanded Approval for Pneumonia

[ Price : $8.95]

FDA approves a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquire...

NuCana Phase 3 Bilary Tract Cancer Study

[ Price : $8.95]

FDA authorizes NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for...

Orthopedic Surgical Instruments Put Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fix...

Draft Guide on Homeopathic Drug Products

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.

Allergan NDA Lo Minastrin FE Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer market...