FDA In Brief: FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications

The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.

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HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs

https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html

07/23/2019

07/16/2019

Indoco Remedies Limited

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

7/23/2019

07/22/2019

Curaleaf, Inc

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

07/23/2019

07/02/2019

High Chemical Company, Div of National Generic Distributors

Division of Pharmaceutical Quality Operations I

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

07/23/2019

06/28/2019

Scientific Solutions Global LLC

Division of Pharmaceutical Quality Operations I

CGMP/Finished Pharmaceuticals/Adulterated

07/23/2019

06/26/2019

Westlab Pharmacy, Inc. dba Westlab Pharmacy

Office of Pharmaceutical Quality Operations, Division II

CGMP/Drug Products/Adulterat

07/30/2019

06/11/2019

Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc.

Division of Human and Animal Food Operations East I

CGMP/Dietary Supplement/Adulterated/Misbranded

Texas Board of Pharmacy Meeting August 6, 2019 Agenda Attached

AUGUST 6, 2019

AGENDA

Stonegate Pharmacy LP, Austin, TX., SRL dated 04/24/2019 - FDA

https://www.fda.gov/media/124964/download

Apr 24, 2019 - The purpose of this letter is to refer to the Texas State Board of Pharmacy (BOP) for appropriate follow up, the U.S. Food and Drug ...