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March 10, 2020

James R. Corbett, M.D. – 603967 – 02/27/2020

Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 20-HFD-45-02-01 Product: Drugs Recipient: Recipient Name James R. Corbett, M.D. James R. Corbett, M.D. 1500 East Medical Center […]
March 10, 2020

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Submit Comments by 05/11/2020 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 […]
March 10, 2020

FDA’s Sentinel Initiative – Background

 Sign up for E-mail Updates At a time when patients and caregivers are demanding more information about the associated benefits and potential risks of the medical […]
March 9, 2020

Phonetic and Orthographic Computer Analysis (POCA) Program

To download the FDA POCA software, click on the following link. Save the installation zip file to your computer and follow the instructions in the POCA […]
March 9, 2020

Outlook Pharmaceuticals, Inc. – 605071 – 02/21/2020

Delivery Method: Facsimile Product: Drugs Recipient: Recipient Name Stefan Antonsson Recipient Title CEO Outlook Pharmaceuticals, Inc. 8044 Montgomery Road, Suite 700Cincinnati, OH 45236United States Issuing Office: […]
March 9, 2020

Nutrishare Inc – 543730 – 03/04/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Rodney J. Okamoto Recipient Title Owner and President Nutrishare Inc 9850 Kent StreetElk Grove, CA 95624United […]
March 9, 2020

Dr. Hahn’s remarks to the FDA/FTC Workshop on a Competitive Marketplace for Biosimilars – 03/09/2020

(Remarks as prepared for delivery) Good morning.  Thank you, Eva [Tempkin], for that kind introduction. I’m pleased to see so many of you joining us – […]
March 9, 2020

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

For Immediate Release: March 09, 2020 Español The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies […]
March 9, 2020

Development Considerations of Antifungal Drugs to Address Unmet Medical Need – 05/07/2020 – 05/07/2020

On This Page Date: May 7, 2020 Time: 9:00 AM – 5:00 PM ET Attend Eventbrite Link Onsite registration will start at 8:00 AM ET Summary […]
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