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December 8, 2020

CDER Small Business and Industry Assistance (SBIA) Learn

Drug Master File (DMF) and Drug Substance Workshop Webinar 3/3/2021 Drug Master Files OTC Monograph Reform in the CARES Act: Safety Orders Webinar 1/27/2021 OTC Drug […]
December 8, 2020

Information for Consumers and Patients | Drugs

Tainted Sexual Enhancement Products Approval, labeling, side effects, and safety Finding and Learning about Side Effects (adverse reactions) Approval, labeling, side effects, and safety Understanding the […]
December 8, 2020

Project Orbis: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies

Image By: Jeet Guram, M.D., Senior Advisor to the Commissioner, R. Angelo de Claro, M.D., Associate Director for Global Clinical Sciences (Acting) in the Oncology Center […]
December 8, 2020

High Blood Pressure–Understanding the Silent Killer

The Who, What, Why, and How of High Blood Pressure  Who is affected by high blood pressure? Approximately 1 in 3, nearly 70 million, American adults […]
December 8, 2020

2017 Meeting Materials, Oncologic Drugs Advisory Committee

2017 Meeting Materials, Oncologic Drugs Advisory Committee | FDA In this section: Oncologic Drugs Advisory Committee Home Advisory Committees Committees and Meeting Materials Human Drug Advisory […]
December 8, 2020

Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry

Docket Number: FDA-2014-D-0622 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research FDA is issuing this guidance to help sponsors of human prescription drug […]
December 8, 2020

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry

Submit Comments by 02/08/2021 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 […]
December 8, 2020

Paradigm RE LLC – 612014 – 12/07/2020

Product: Drugs Date:               December 7, 2020 RE:      Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United […]
December 8, 2020

Valentus, Inc. – 609611 – 11/30/2020

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Dave Jordan Recipient Title Owner Valentus, Inc. 3900 W. 53rd StreetSioux Falls, SD 57106-4220United States […]
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