Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Rachael Pontikes ordered by Published Date Descending.
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FDA Partners With The National Association Of Boards Of Pharmacy To Create An Information-Sharing System For Drug Compounding Activities
On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP)
United States
17 Oct 2019
Outsourcing Facility Athenex Withdraws Appeal Of District Court's Ruling On FDA's Placement Of Bulk Drug Substances On Its "Clinical Need" List
On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of Columbia's ruling related ...
United States
7 Oct 2019
Recent Traction In FDA's Development Of The 503A And 503B Bulks Lists
Just as the U.S. Food & Drug Administration ("FDA") promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register
United States
11 Sep 2019
DOJ Addresses FDA Jurisdiction Over Capital Punishment Drugs
In May 2019, the Department of Justice, Office of Legal Counsel ("OLC") issued a slip opinion addressing the Food and Drug Administration's
United States
4 Jul 2019
FDA Issues 2019 Goals To Improve The Quality Of Compounded Drugs
Just prior to departing the FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement on the Agency's 2019 goals to improve the quality of compounded drugs.
United States
26 Apr 2019
To Close Out 2018, FDA Published A Revised Draft Guidance On Human Drug Compounding For Outsourcing Facilities
In accordance with the United States Food & Drug Administration's ("FDA") 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities.
United States
1 Feb 2019
FDA Withdraws Draft Guidance For Industry #230
The U.S. Food & Drug Administration ("FDA") announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, "Compounding Animal Drugs from Bulk Drug Substances."
United States
8 Nov 2017
Recently Released Enhanced Regulatory Initiatives for Drug Compounders
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA's ramped up regulatory initiatives for drug compounders.
United States
2 Oct 2017
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