FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Catalent Brussels Plant Inspected Again

[ Price : $8.95]

For the second time in a year, FDA inspects contract manufacturer Catalents Brussels, Belgium, manufacturing facility.

Comments Extended on Non-Rx Drug Proposed Rule

[ Price : $8.95]

Federal Register notice: FDA extends the comment period for a 6/28 proposed rule entitled Nonprescription Drug Product With an Add...

Draft Guide on Breakthrough Devices Program

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Breakthrough Devices Program Guidanc...

Guide on Drug Trial Multi-Endpoints

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Multiple Endpoints in Clinical Trials.

FDA Extends Compounded Drug Enforcement Discretion

[ Price : $8.95]

Federal Register notice: FDA extends the period before it intends to begin enforcing a statutory 5% limit on distribution of compo...

FDA Continues Paired Meetings on Trial Designs

[ Price : $8.95]

Federal Register notice: FDA announces the continuation of its paired meeting program that aims to advance the use of complex inno...

Guide on Gene Therapies for Neurodegenerative Diseases

[ Price : $8.95]

FDA posts a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases.

Bristol Myers sNDA for Camzyos

[ Price : $8.95]

FDA accepts for review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the n...

FDA Releases Guidances on Generic Topical Drugs

[ Price : $8.95]

FDA posts three FDA draft guidances that provide general recommendations for physicochemical and structural characterization tests...

Paper Calls for FDA Reforms on Transparency/Evidence

[ Price : $8.95]

A white paper commissioned by Georgetown University says changes are needed at FDA because its evidence standards have become dist...