FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on 510(k) Transfers/Sales

[ Price : $8.95]

FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.

Pandemic Diagnostic Testing Plan Needed: GAO

[ Price : $8.95]

The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated nation...

2 FDA Officials Part of Wrongful Termination Lawsuit

[ Price : $8.95]

Two former FDA officials add their names to a class-action wrongful termination lawsuit alleging the federal government knowingly ...

Sources Question FDA Internal AI: NBC

[ Price : $8.95]

Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.

Makary Pledges Mifepristone Study

[ Price : $8.95]

FDA commissioner Martin Makary says agency scientists will review the safety of the abortion drug mifepristone based on findings f...

Makary Struggles to Clarify New Covid Recommendations

[ Price : $8.95]

FDA commissioner Marty Makary appears to struggle to convey the governments Covid-19 vaccine recommendations in a contentious inte...

Rechon Life Sciences Violations

[ Price : $8.95]

FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.

CGMP Violations at Zhejiang Easyclean

[ Price : $8.95]

FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Drops LDT Regulation, Looks to RUOs: Attorneys

[ Price : $8.95]

Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintai...

CBERs Prasad Outlines Rare Disease Goals

[ Price : $8.95]

CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoin...