FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Draft Guide on Drug Supply Security

[ Price : $8.95]

Federal Register notice: FDA announces the availability of a draft guidance on Identifying Trading Partners Under the Drug Supply ...

New Version of CDISC Data Standards Available

[ Price : $8.95]

Federal Register notice: CDER has announced its support for the 3.1 version of Clinical Data Interchange Standards Consortium Stan...

FDA Approves Ironwood Pharma NDA for Gout Patients

[ Price : $8.95]

FDA approves an Ironwood Pharmaceuticals NDA for Duzallo (allopurinol and lesinurad) as a once-daily oral treatment for hyperurice...

Guidance on FDA accepting Gifts on Behalf of U.S.

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Comments Sought on Device Pediatric Info Collection

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Re...

Guidance on CVM Blood Level Bioequivalence Studies

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.

Guidance on FDA accepting Gifts on Behalf of U.S.

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Agios Pharma Stops Drug Development After FDA Hold

[ Price : $8.95]

Agios Pharmaceuticals pulls the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and with...

Janssen Biotech sBLA for Stelara in Adolescents

[ Price : $8.95]

Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age...

FDA Allows Pfizer to Remove Boxed Warning From Chantix

[ Price : $8.95]

FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric e...