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November 1, 2022
Published by Med Search on November 1, 2022
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Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Lou Wood Kennedy Recipient Title CEO and Owner Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, […]
November 1, 2022
Published by Med Search on November 1, 2022
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Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jim McConnell Recipient Title President McConnell Labs Inc. 406 SW Umatilla Ave.Redmond, OR 97756United States Issuing […]
October 31, 2022
Published by Med Search on October 31, 2022
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Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try […]
October 31, 2022
Published by Med Search on October 31, 2022
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The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing […]
October 31, 2022
Published by Med Search on October 31, 2022
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As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug […]
October 31, 2022
Published by Med Search on October 31, 2022
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Docket Number: FDA-2022-D-0760 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs This guidance is intended to assist sponsors in […]
October 28, 2022
Published by Med Search on October 28, 2022
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Response: The CID Paired Meeting Program is the PDUFA VII continuation of the CID Pilot Meeting Program established under the sixth iteration of the Prescription Drugs […]
October 27, 2022
Published by Med Search on October 27, 2022
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FDA will work with the National Association of Boards of Pharmacy (NABP) to raise state awareness of available trainings sponsored by FDA’s Compounding Quality Center of […]
October 27, 2022
Published by Med Search on October 27, 2022
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Submit Comments by 12/27/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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