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December 21, 2020

Rowpar Pharmeceuticals – 611759 – 12/18/2020

Product: Drugs Recipient: Recipient Name James Ratcliff Recipient Title CEO Rowpar Pharmeceuticals 16100 N. Greenway Hayden Loop #400Scottsdale, AZ 85260United States [email protected] [email protected] Date:               December […]
December 18, 2020

Dry Eye: Developing Drugs for Treatment Guidance for Industry

Submit Comments by 03/17/2021 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 18, 2020

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

For Immediate Release: December 18, 2020 Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell […]
December 18, 2020

Resources for the Animal Model Qualification Program

Content current as of: 12/18/2020 Regulated Product(s) Topic(s) Law(s) & Regulation(s)
December 18, 2020

Overview of the Animal Model Qualification Program

The Animal Model Qualification Program (AMQP) is a Drug Development Tool Qualification Program specifically established to address the need for publicly available, product-independent animal models intended […]
December 18, 2020

The Animal Model Qualification Process

The qualification process comprises FDA review of specific documents submitted to the AMQP in three successive stages (i.e., Stage 1 – Letter of Intent, Stage 2 […]
December 18, 2020

Generic Drugs Stakeholder Toolkit

The following information is provided to help you promote FDA as a resource for information on generic medications and encourage prescribers and patients to talk to […]
December 18, 2020

Compounding Quality Center of Excellence | Training Programs

The Compounding Quality Center of Excellence’s training program, geared toward outsourcing facilities, provides training opportunities on manufacturing quality and other policies pertaining to outsourcing facilities, including […]
December 18, 2020

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

For Immediate Release: December 18, 2020 Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.  […]
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