The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.S. The program, called FDA PreCheck, was created in response to a May 5 executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. 
 
The program consists of a two-phase approach to facilitate new manufacturing facilities. The first provides manufacturers with more frequent FDA communication during stages such as facility design, construction and pre-production. The second focuses on streamlining development of the chemistry, manufacturing and controls section of the drug application through pre-application meetings and early feedback. 
 

Related News Articles

Headline
A JAMA study published Aug. 20 found that nearly 63% of all U.S. drug production facilities from 2019 through 2024 were in counties where a weather disaster…
Headline
The Department of Health and Human Services and the Centers for Medicare & Medicaid Services Aug. 21 announced the creation of a Healthcare Advisory…
Headline
B. Braun Medical has voluntarily recalled two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL IV fluids due to…
Headline
The White House Aug. 13 released an executive order directing the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness…
Headline
The Food and Drug Administration has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings.…
Headline
The Food and Drug Administration Aug. 8 announced an end to the national shortage of sodium chloride 0.9% IV solutions products. The agency said it continues…