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On September 20, 2023, the U.S. Court of Appeals for the Ninth Circuit held in United States v. Marschall, 2023 U.S. App. LEXIS 24886 (9th Cir. Sept. 20, 2023), that certain felony...

FDA passed Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications TTP Establishes framework for the accreditation of CBs to conduct food safety audits and issue facility and food certifications to eligible entities

New York, NY (PRWEB) January 18, 2022 -- Side, the only real estate brokerage platform that partners exclusively with the industry’s top agents, teams, and

In March 2020, the Food and Drug Administration (FDA) issued temporary guidance documents allowing for the increased production of alcohol-based hand sanitizer during the COVID-19...

FDA is withdrawing a trio of temporary policies implemented in the beginning of the COVID pandemic which allowed certain businesses that are not regulated as drug manufacturers, including pharmacies and alcohol producers, to produce alcohol-based hand sanitizers.

FDA is withdrawing temporary policies for manufacturers that were not drug manufacturers to produce hand sanitizers during the PHE. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers relying on these policies must cease production of products.

On Tuesday, October 12, 2021, the US Food and Drug Administration (FDA) announced that it will withdraw the temporary policies originally issued in March 2020 for manufacturers that...

Certifying Pharmaceutical Exports: An Introduction To FDAs Certificate Of Pharmaceutical Product By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharm...

Originally published on December 30, 2020, this article was last updated on January 6, 2021. On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts pending approval from the Secretary of the Department of Health and Human Services (HHS). The withdrawal notice states that the original notice issued without such Secretarial approval...