U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on January 12, 2026 - 06:05 GMT

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

For Immediate Release: January 11, 2026 The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies ( …

Distribution channels: Food & Beverage Industry

Published on January 9, 2026 - 23:15 GMT

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026

This is the list of guidance topics the Center for Biologics Evaluation and Research (CBER) is considering for development during Calendar Year 2026. The list includes topics that currently have no guidance associated with them, topics where updated …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2026 - 23:15 GMT

2026 Safety and Availability Communications

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2026 - 22:05 GMT

Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on January 9, 2026 - 20:02 GMT

HerbsForever LLC Issues Allergy Alert on Undeclared Wheat in HerbsForever brand Dietary Supplements

GOVERNMENT AGENCY PARTNER ANNOUNCEMENT When a Government Agency Partner announces a company’s recall, market withdrawal, or safety alert, the FDA posts the Government Agency Partner’s announcement as a public service. FDA does not endorse either the …

Distribution channels: Food & Beverage Industry

Published on January 9, 2026 - 18:22 GMT

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2026 - 14:11 GMT

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

Docket Number: FDA-2025-D-3217 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This draft guidance provides guidance to sponsors and applicants submitting investigational new drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2026 - 14:11 GMT

Importing Liquid Cough and Cold Medicine from India

FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. FDA expects imported liquid cough and cold medicine at risk for DEG and EG contamination …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2026 - 21:34 GMT

Gusto Group Inc. Recalls Shrimp Paste (Klong Kone) ‘'454 G. (1 LBS)’ and ‘910 G. (2 LBS)’ because of Possible Health Risk

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on January 8, 2026 - 19:59 GMT

BK251245- Procleix® WNV/ Babesia Quality Control

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2026 - 19:59 GMT

BK251248- PRiSM PRP

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2026 - 19:59 GMT

BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 ...

510(k) Number: BK251286 Applicant: Roche Molecular Systems, Inc Device Name: a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems; b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2026 - 19:59 GMT

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

FDA News Release Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events For Immediate Release: April 23, 2021 Following a thorough safety review, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2026 - 16:41 GMT

FDA/Center for Research on Complex Generics (CRCG) Workshop on Visionary Standards: Advancing Science and Regulation in Generic ...

Date: November 19 - 20, 2025 Time: 8:30 a.m. - 5:00 p.m. ET Location: Event Location The Universities at Shady Grove Building II 9630 Gudelsky Drive Rockville, MD 20850 United States Event Website Event Details This 2-day hybrid workshop will explore the …

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Published on January 7, 2026 - 22:24 GMT

FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 - 01/21/2026

Date: January 21, 2026 Time: 1:00 p.m. - 2:30 p.m. ET Join the Event on January 21, 2026 No Registration is Required for this Free Virtual Information Session Attendance Details This information session will be hosted virtually on Microsoft Teams. On the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2026 - 20:07 GMT

Carrot Top Kitchens of Bridgeport (formerly Redding) Issues a Class II Recall of Hummus Containing Undeclared Sesame

GOVERNMENT AGENCY PARTNER ANNOUNCEMENT When a Government Agency Partner announces a company’s recall, market withdrawal, or safety alert, the FDA posts the Government Agency Partner’s announcement as a public service. FDA does not endorse either the …

Distribution channels: Food & Beverage Industry

Published on January 7, 2026 - 02:24 GMT

Cleared 510(k) Submissions with Supporting Documents - 2026

This list includes cleared 510(k) submissions for 2026 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change. The clearances are …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2026 - 20:15 GMT

CBER Advanced Technologies Program

FDA regulates pharmaceutical products to ensure a continuous supply of high-quality products in the United States. In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2026 - 14:51 GMT

What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding

Image Cannabis and Cannabis-derived products have become increasingly available in recent years, with new and different types of products appearing all the time. These products raise questions and concerns for many consumers. And if you are pregnant or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2026 - 14:51 GMT

Tower Laboratories Ltd. - 717456 - 12/23/2025

Delivery Method: Via Email Return Receipt Requested Reference #: 320-26-33 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Norman Needleman Recipient Title Chief Executive Officer Tower Laboratories Ltd. 8060 Whitbeck Road Montague, MI …

Distribution channels: Healthcare & Pharmaceuticals Industry