fbpx
March 10, 2020

Drug Trials Snapshots: BARHEMSYS

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 10, 2020

Compounding Quality Center of Excellence: In-Person Training Programs

The Compounding Quality Center of Excellence’s in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and […]
March 10, 2020

Q3D(R1) ELEMENTAL IMPURITIES

Docket Number: FDA-2013-D-1156 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0