FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDER Caught Up on Domestic Pre-approval Inspections: Cavazzoni

[ Price : $8.95]

CDER director Patrizia Cavazzoni puts a positive spin on drug inspections, user fee goals, and enforcement and compliance activiti...

FDA Approves Rhythm Pharma sNDA for Imcivree

[ Price : $8.95]

FDA approves a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight manage...

Guide on Regenerative Medicines Consensus Standards

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Voluntary Consensus Standards Recognition Program for Regen...

Info Collection Revision on CLIA Waivers

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Administrative Procedures for Clinical ...

Advisors to Consider Acadias Nuplazid for Alzheimers Psychosis

[ Price : $8.95]

FDA says its Psychopharmacologic Drugs Advisory Committee will consider whether data from Acadia Pharmaceutical trials support an ...

Alston & Bird Attorneys Review PDUFA 7 Provisions

[ Price : $8.95]

Four Alston & Bird attorneys describe some of the major items in the PDUFA 7 reauthorization legislation that has bipartisan suppo...

Pfizer Stops Enrolling Standard Risk Patients in Paxlovid Trial

[ Price : $8.95]

Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data ...

Senate HELP Committee Passes FDA User Fee Bill

[ Price : $8.95]

The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which rea...

Draft Guide on Quality Risk Management

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance for industry entitled Q9(R1) Quality Risk Management (QRM).

CDERs Cavazzoni Spearheading Rare Disease Program

[ Price : $8.95]

CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Centers new rare disease efforts to speed and incre...