Search
Searching Content by Rachael Pontikes ordered by Published Date Descending.
Links to Result pages
 
1  
 
Title
Country
Organisation
Author
Date
1
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
2
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
3
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
4
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
5
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
6
To Close Out 2018, FDA Published A Revised Draft Guidance On Human Drug Compounding For Outsourcing Facilities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Drug Administration's ("FDA") 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities.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
7
FDA Withdraws Draft Guidance For Industry #230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Drug Administration ("FDA") announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, "Compounding Animal Drugs from Bulk Drug Substances."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
8
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
Links to Result pages
 
1