FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP and Other Violations at DSP Skin Care

[ Price : $8.95]

FDA warns Los Angeles, CA-based DSP Skin Care about CGMP and other violations, some repeated from 2018, in its manufacturing of fi...

Allarity Refocuses in Response to FDA Comments

[ Price : $8.95]

Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers a...

IND-Exempt BA/BE Study Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE stud...

Guide on N-Acetyl-L-Cysteine Enforcement Discretion

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.

Regulatory Review Period for Rozlytrek

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablet...

FDA Permanently Debars Duniel Tejeda

[ Price : $8.95]

Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an appr...

$229 Million Boost in Senate FDA Budget Bill

[ Price : $8.95]

The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by...

Accelerated Approval Program Largely Successful: Analysis

[ Price : $8.95]

An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug out...

CDRH Still Working on AL/MI Guidance: Attorneys

[ Price : $8.95]

Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing ...

bioMrieux Kidney Injury Assay Cleared

[ Price : $8.95]

FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.