FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study

[ Price : $8.95]

FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerli...

Mass Compounding Threatens FDA Enforcement: Column

[ Price : $8.95]

An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.

Medline Industries QS Violations Cited

[ Price : $8.95]

FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovasc...

FDA Opens READI-Home Innovation Challenge

[ Price : $8.95]

FDA solicits applications for its new READI-Home innovation challenge to use medical technology in the home to reduce or prevent h...

Groups Urge Congress to Advance Generic Drug Bills

[ Price : $8.95]

Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowerin...

FDA Grants Outlook Therapeutics Dispute Resolution Request

[ Price : $8.95]

FDA agrees to hear an Outlook Therapeutics formal dispute resolution request regarding the agencys prior rejection of eye disease ...

Federal Judge Pauses Challenge to Abortion Pill Rules

[ Price : $8.95]

A federal judge declines to immediately restrict access to the abortion pill mifepristone, instead pausing a high-profile lawsuit ...

Doctor Failed to Follow Investigational Plan: FDA

[ Price : $8.95]

FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.

Workshop on Improving Pregnancy Drug Safety Registries

[ Price : $8.95]

FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the saf...

Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

[ Price : $8.95]

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis ...