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FDA releases its latest batch of Warning Letters that includes Biomin Industries and Guangdong Zhanjiang Jimin Pharmaceutical Co.[ Price : $8.95]
A JAMA viewpoint piece urges medical journal editors to encourage study authors to disclose CDRHs role in clinical trial design an...[ Price : $8.95]
Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age...[ Price : $8.95]
FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric e...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Re...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.