FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

SCOTUS Decisions Effect on FDA Analyzed

[ Price : $8.95]

Six Squire Patton Boggs attorneys lay out the impact of four recent Supreme Court decisions on several aspects of FDA regulation.

QS Issues at American Contract

[ Price : $8.95]

FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of st...

CGMP Violations in Zhejiang Qimei Records Review

[ Price : $8.95]

FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.

Abeona Skin Disorder BLA Resubmission Accepted

[ Price : $8.95]

FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients w...

Nuplazid Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due...

Workshop on Optimizing Real-World Evidence Use

[ Price : $8.95]

Federal Register notice: FDA announces a 12/12 public workshop titled Optimizing the Use of Real-World Evidence in Regulatory Deci...

House Republicans Want GAO Lab Safety Review

[ Price : $8.95]

House Energy and Commerce Committee Republicans ask for a GAO review of laboratory safety in FDA, CDC, and NIH, citing previous GA...

FDA Warns Taiwanese, Australian X-ray Firms

[ Price : $8.95]

FDA warns two firms in Taiwan and Australia about Quality System violations in their manufacturing of x-ray equipment.

Complete Response Letter on Ocaliva sNDA

[ Price : $8.95]

FDA sends Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to c...

Disappointed Califf on Possible Disruption at FDA

[ Price : $8.95]

FDA commissioner Robert Califf tells Friends of Cancer Researchs annual meeting that he is personally disappointed in the election...