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March 17, 2020

Drug Interactions: What You Should Know

(PDF version – 68KB) There are more opportunities today than ever before to learn about your health and to take better care of yourself. It is […]
March 17, 2020

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

Applications Affected by the Reorganization of the Office of New Drugs In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to […]
March 17, 2020

Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure

Alpha-1-antitrypsin deficiency Patients with congenital alpha-1 antitrypsin deficiency Plasma alpha-1 proteinase inhibitor Traditional Alpha-1 protease inhibitor augmentation Acromegaly  Patients with acromegaly who don’t respond to or […]
March 17, 2020

Windlas Healthcare Private Limited – 595494 – 03/10/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Hitesh Windlass Recipient Title Managing Director Windlas Healthcare Private Limited Plot No. 183 & 192, Mohabewala […]
March 17, 2020

GOJO Industries Inc – 599132 – 01/17/2020

Delivery Method: UPS & Electronic Mail Product: Drugs Recipient: Recipient Name Carey Jaros Recipient Title President and Chief Executive Officer GOJO Industries Inc 3783 State RoadCuyahoga […]
March 17, 2020

Warner Herb Co. – 586299 – 02/21/2020

Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name John E. Warner Recipient Title Owner Warner Herb Co. 7365 Highway 127 SouthCrossville, TN 38572United States […]
March 17, 2020

Cipla Limited – 597511 – 02/25/2020

Delivery Method: VIA UPS Reference #: 320-20-26 Product: Drugs Recipient: Recipient Name Mr. Umang Vohra Recipient Title Managing Director and Global CEO Cipla Limited Cipla House, […]
March 17, 2020

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry

Submit Comments by 05/18/2020 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 17, 2020

Compounding: Inspections, Recalls, and other Actions

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