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Federal Register Notice: FDA announces the names of the members who will serve on its Performance Review Board that will review se...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection extension submitted to OMB related to Applications for Pa...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Dongying Tiandong Pharmaceutical Co. and STI Pharma.[ Price : $8.95]
FDA approves a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg generic versions of Cephalons Nuvigil, in...[ Price : $8.95]
FDA accepts for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma.[ Price : $8.95]
FDA posts a guidance on Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexibl...[ Price : $8.95]
Federal Register Final Rule: FDA issues a final rule to establish requirements for the electronic filing of entries of FDA-regulat...[ Price : $8.95]
FDA releases a guidance on Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evalua...