Biosimilars Guidances

by Pill Pals Customer Service | Sep 8, 2025 | News

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact...

Safety Labeling Change Orders

by Pill Pals Customer Service | Sep 8, 2025 | News

3/14/2025ANDA-070765, ANDA-070766Chlordiazepoxide and Amitriptyline HydrochlorideANDA REPOSITORY, LLCArchive4/28/2023NDA-019758Clozaril (Clozapine)HERITAGE LIFE SCIENCES BARBADOS INCArchive9/20/2021NDA-018936Prozac (Fluoxetine Hydrochloride)ELI LILLY AND...

Guidance for Industry

by Pill Pals Customer Service | Sep 8, 2025 | News

Docket Number: FDA-2023-D-1955 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3)...

Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination

by Pill Pals Customer Service | Sep 8, 2025 | News

Summary Company Announcement Date: September 05, 2025 FDA Publish Date: September 08, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with-Listeria...

Comparative Epidemiology of Salmonella Paratyphi A and Salmonella Typhi Causing Enteric Fever, Bangladesh, 2018–2020

by Pill Pals Customer Service | Sep 8, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Sadia Isfat Ara Rahman1 , Md Golam Firoj1, Se Eun Park1, Farhana Khanam1, Suneth Agampodi1,...

FDA’s Sixth Online Controlled Substances Summit

by Pill Pals Customer Service | Sep 8, 2025 | News

On This Page Date: September 11, 2025 Time: 12:30 p.m. – 3:30 p.m. ET FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online Controlled Substances Summit.Illegal online sales of controlled substances pose significant health risks to...