Athenex Loses FDA Fight Over Bulk Drug Substance Vasopressin

https://news.bloomberglaw.com/.../athenex-loses-fda-fight-over-bulk-drug-substance-...

20 hours ago - Athenex will stop producing compounded vasopressin for patients with low blood pressure due to ... FDA excluded compound's active ingredient from bulk substance list; Method for ... Endo a Winner in FDA Bulk Drug Compounding Move.

Compounding Certificate Application - the Mississippi Board of ...

https://www.mbp.ms.gov/Documents/2019_Compounding_Application_Fillable.pdf

3 days ago - licensing@mbp.ms.gov. COMPOUNDING CERTIFICATE APPLICATION. January 1, 2020 – December 31, 2021. Are you compounding: Sterile. Non-Sterile.

Endo Applauds U.S. District Court Decision that Vasopressin Cannot be Used for Compounding by Outsourcing Facilities

Court rules in Endo's favor in compounding case - The Pharma Letter

https://www.thepharmaletter.com/.../court-rules-in-endo-s-favor-in-compounding-case

1 day ago - The latest court decision follows an FDA decision in March not to list the antidiuretic hormone on the list of bulk drug substances permitted to be compounded ...

Endo Applauds U.S. District Court Decision that Vasopressin Cannot ...

https://www.prnewswire.com/.../endo-applauds-us-district-court-decision-that-vasopre...

1 day ago - Endo Applauds U.S. District Court Decision that Vasopressin Cannot be Used for Compounding by Outsourcing Facilities. News provided by. Endo International ...

Agenda | Compounding Pharmacy Compliance West - 09/17/2019 ...

www.cbinet.com/conference/agenda/fc19217

2 days ago - 9:00. PANEL Review FDA Guidance on Use of Bulk Substances and Essential Copies. MODERATOR: Lee Rosebush Partner BakerHostetler. PANELISTS:.

Updates to USP Compounding Chapters Are on the Horizon

https://www.pharmacytimes.com/.../updates-to-usp-compounding-chapters-are-on-the...

6 days ago - It is crunch time. Changes are coming to United States Pharmacopeia (USP) compounding chapter <800>, “Hazardous Drugs — Handling in Healthcar

FDA Limits On Vasopressin Compounding Valid, Says Judge

https://www.law360.com/articles/1184497/fda-limits-on-vasopressin-compounding-valid-says-judge

The U.S. District Court for the District of Columbia has ruled in FDA's favor in a compounding case

Court Sides With FDA in Compounding Lawsuit | 2019-08-02 | FDANews

https://www.fdanews.com/.../192236-court-sides-with-fda-in-compounding-lawsuit

4 hours ago - The U.S. District Court for the District of Columbia has ruled in FDA's favor in a compounding case, deciding that the agency was right in barring a company from ...

Compounder loses battle with the FDA over using bulk substances

Compounder loses battle with the FDA over using bulk substances - Stat

https://www.statnews.com/pharmalot/2019/.../compounder-fda-bulk-substances-endo/

21 hours ago - A federal judge ruled the Food and Drug Administration correctly prevented a company from using an ingredient to make a compounded version of a medicine ...

How an epic legal battle brought a secret drug database to light

https://www.washingtonpost.com/health/how-an-epic-legal-battle-brought-a-secret-drug-database-to-light/2019/08/02/3bc594ce-b3d4-11e9-951e-de024209545d_story.html?utm_term=.acb41039f25c

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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