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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Biomin Industries and Guangdong Zhanjiang Jimin Pharmaceutical Co.

CDRH Role in Device Trial Design Should be Disclosed: JAMA

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A JAMA viewpoint piece urges medical journal editors to encourage study authors to disclose CDRHs role in clinical trial design an...

Janssen Biotech sBLA for Stelara in Adolescents

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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

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

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

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

Comments Sought on Device Pediatric Info Collection

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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

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

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

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

Agios Pharma Stops Drug Development After FDA Hold

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

Feds Recover $2.5 Billion in Healthcare False Claims

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The Justice Department says healthcare False Claims Act recoveries totaled $2.5 billion in FY 2016.