FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on IND Safety Reporting Assessment

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Safety Assessment for IND Safety Reporting.

FDA OKs ANI Pharmas Generic Miralax

[ Price : $8.95]

FDA approves an ANI Pharmaceuticals ANDA for polyethylene glycol 3350 powder for oral solution, 17mg per scoopful, a generic copy ...

Catalyst Files NDA for Firdapse

[ Price : $8.95]

Catalyst Pharmaceuticals completes a rolling NDA submission for Firdapse (amifampridine phosphate), indicated for treating Lambert...

Dont Work on Only 510(k) Content: Consultant

[ Price : $8.95]

Consultant Jon Speer cautions medical device companies not to ignore quality management, design control, and risk management when ...

Stakeholders Praise, Challenge FDA Patient Engagement Ideas

[ Price : $8.95]

Stakeholders praise and criticize FDA for its approach to creating a CDRH patient engagement advisory committee.

Fraud Recovery Amount Down This Year: Attorney

[ Price : $8.95]

Attorney Alison Nadel says the federal government says that its recoveries from False Claims Act cases have exceeded $3.5 billion ...

Qualitest Settles Whistleblower Suit for $39 Million

[ Price : $8.95]

Qualitest Pharmaceuticals agrees to pay $39 million to the federal and several state governments to resolve civil fraud claims ari...

Appeals Court Says Motrin Case Should Have Proceeded

[ Price : $8.95]

An Oregon appeals court says the states suit against Johnson & Johnson over its silent recall of defective Motrin should have gone...

Info on Clinical Trial Oversight Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a guidance on the oversight of clinical investigation...

Meeting on Biotechnology-Derived Drugs

[ Price : $8.95]

Federal Register Notice: CDER and the International Separation Science Society will sponsor a meeting 1/26/16 to discuss the devel...