FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Opens Clinical Investigation Technology Docket

[ Price : $8.95]

FDA solicits comments on using technologies and innovative methods in clinical investigations.

Multiple Violations on Noven FDA-483

[ Price : $8.95]

FDA releases an FDS-483 detailing 13 violations found in a Noven Pharmaceuticals inspection.

Concerns About Biologics Naming Guidance

[ Price : $8.95]

Stakeholders express concerns about an FDA draft guidance on biologic naming.

Most People Want FDA Ad Review

[ Price : $8.95]

A Kaiser Family Foundation health tracking poll finds that people think drug companies spend too much on advertising to patients a...

Comments Sought on IDE Reports/Records

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection on investigational device exemptions reports and records.

FDA, Pacira in Settlement Talks About Off-label Promotion

[ Price : $8.95]

FDA and Pacira Pharmaceuticals enter settlement talks to resolve a recent lawsuit or narrow the dispute brought against the agency...

ANDA Consolidation MAPP Out

[ Price : $8.95]

The CDER Office of Generic Drugs issues a MAPP with the process for reviewing and approving or denying requests for consolidation ...

Cubist Seeks Dificid ANDA BE Requirements

[ Price : $8.95]

Cubist asks FDA to impose specific bioequivalence requirements on ANDA and 505(b)(2) NDA applicants citing Dificid as the referenc...

FDA Wants to Simplify GDUFA 2 with High Impact Changes

[ Price : $8.95]

CDER says that a main fundamental goal for negotiating the Generic Drug User Fee Act reauthorization will be to align with Industr...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Aros Surgical Instruments and SSM Health Care dba SSM St. Clare Health Center.