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24 May 2022, 10:00 pm
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ”  (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to… [read post]
24 May 2022, 10:00 pm
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ”  (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to… [read post]
24 May 2022, 10:00 pm
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ”  (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to… [read post]
24 May 2022, 10:00 pm
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ”  (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to… [read post]
24 May 2022, 10:00 pm
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ”  (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to… [read post]
24 May 2022, 8:30 pm by Bill Marler
The Illinois Department of Public Health (IDPH) is working with local health departments, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Senftenberg. [read post]
24 May 2022, 4:23 pm by Bill Marler
MAYNE, PH.D.DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THESUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS COMMITTEE ON ENERGY AND COMMERCEU.S. [read post]
24 May 2022, 11:39 am by Katherine Pompilio
According to the Centers for Disease Control and Prevention, the U.S. emergency vaccine reserve holds two Food and Drug Administration-approved vaccines that could be used to contain the spread of the virus. [read post]
23 May 2022, 9:03 pm by Coral Beach
“Contamination can occur at any point in the supply chain, but the seeds themselves are the most likely source of contamination in many of these outbreaks,” according to the Food and Drug Administration. [read post]
22 May 2022, 9:01 pm by News Desk
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
22 May 2022, 6:53 am by Ben Vernia
Food and Drug Administration (FDA) cleared the Prometheus rectal pressure sensor to be used as a single-user device and the anorectal manometry catheter to be used as a single-use device. [read post]
21 May 2022, 7:06 pm by Bill Marler
Stephen Sundlof of the Food and Drug Administration told lawmakers that agency inspectors will start to routinely collect samples for bacterial testing whenever they go into a peanut butter manufacturing facility. [read post]
21 May 2022, 10:22 am by Coral Beach
Smucker Company’s production facility in Lexington, KY, according to the Food and Drug Administration. [read post]
19 May 2022, 9:06 pm by Coral Beach
If approved by the Senate, the measure would provide emergency funding for the Food and Drug Administration in an effort to help alleviate the current shortfall and head off future shortages. [read post]
19 May 2022, 9:05 pm by Sam Wong
Food and Drug Administration (FDA) issued guidance that temporarily provides greater flexibility regarding the importation of certain formulas. [read post]
19 May 2022, 7:05 am by Ameet Sarpatwari
Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration. [read post]
19 May 2022, 6:03 am by Kevin Kaufman
If the Food and Drug Administration bans menthol cigarettes, federal and state governments, combined, stand to lose more than $6.6 billion in the first full year following prohibition. [read post]