U.S. Food and Drug Administration Press Releases

• Published on July 12, 2024 - 21:52 GMT

  

  FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie

  The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 12, 2024 - 21:52 GMT

  

  FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

  en Español Drug Safety Communication (PDF - 59KB) 09-24-2020  FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 12, 2024 - 21:52 GMT

  

  FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

  [8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 12, 2024 - 20:34 GMT

  

  FDA Roundup: July 12, 2024

  For Immediate Release: July 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Wednesday, the FDA issued a Letter to Health Care Providers to notify providers that we are aware the …

  Distribution channels: Food & Beverage Industry
• Published on July 12, 2024 - 19:40 GMT

  

  Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the ...

  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 Summary Company …

  Distribution channels: Food & Beverage Industry
• Published on July 12, 2024 - 19:40 GMT

  

  AB World Foods US, Inc. Recalls Al’Fez Natural Tahini 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 July 12, 2024 - 18:34 GMT

  

  Kenya and Uganda partner with international stakeholders to protect consumers from illicit medical products

  Pharmacy Poisons Board of Kenya National Drug Authority of Uganda FOR IMMEDIATE RELEASE Friday, July 12, 2024 Unprecedented Multilateral Initiative Brings Focus to the Shared Threat Posed by Illicit Medical Products Today, the Pharmacy and Poisons Board ( …

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• Published on July 12, 2024 - 18:33 GMT

  

  Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups - 03/30/2021

  Education | In Person Scheduled On This Page Date: March 30 - 31, 2021 Day1: Tue, Mar 30 9:00 AM - 4:30 PM ET Day2: Wed, Mar 31 9:00 AM - 4:30 PM ET Visit the CDER Small Business and Industry Assistance Webpage Agenda Download Slides This conference is  …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 12, 2024 - 18:02 GMT

  

  Wiers Farm, Inc Issues a Voluntary Recall on Whole and Salad Cucumbers Due to Possible Contamination with Listeria

  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 July 12, 2024 - 02:17 GMT

  

  Frequently Asked Question on Children’s Cough and Cold Medicines

  Questions about Colds in Children Q: Is there a cure for a cold? There’s no cure for the common cold, a viral infection that can’t be treated with antibiotics. Typically, a cold will run its course in a week or two, and children will usually get better on …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 20:36 GMT

  

  Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients ...

  A U.S. Food and Drug Administration (FDA) review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (Lamictal). …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 20:36 GMT

  

  FDA warns that vapors from alcohol-based hand sanitizers can have side effects

  Listen Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. On June 16, 2021, FDA warned that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 20:17 GMT

  

  Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - ...

  On This Page Date: September 20, 2024 Time: 11:00 AM - 4:30 PM ET The FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 20:17 GMT

  

  2024 CBER Patient and Care Partner Listening Meetings

    Gene therapy has recently emerged as a treatment option for some rare diseases with unmet needs. The FDA approved the first gene therapy in 2017 and 19 gene therapies as of June 2024, many of which are for rare diseases. Clinical trials that support …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 20:17 GMT

  

  Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases

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  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 18:22 GMT

  

  Office of Pharmaceutical Quality (OPQ) Reorganization - 07/11/2024

  On This Page Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA) FDA is announcing a webinar on the reorganization of the Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ). …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 13:51 GMT

  

  Information for Health Care Professionals | Drugs

  Review resources for your patients about specific drugs, buying medicine safely, and using medicine safely. The FDALabel database offers detailed drug labels for FDA-approved medications, including reported side effects and clinical trial results. …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 10, 2024 - 22:25 GMT

  

  Baxter Issues Urgent Medical Device Recall for Life2000 Ventilator Due to Potential Battery Charger Dongle Damage

  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 Summary Company …

  Distribution channels: Food & Beverage Industry
• Published on July 10, 2024 - 21:38 GMT

  

  Other Fraudulent Products

  FDA is notifying consumers of certain products promoted for various conditions including skin conditions and sleep aids that have been found to contain hidden ingredients and may pose a significant health risk. The public notifications listed below include …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 10, 2024 - 21:12 GMT

  

  Vail-Bon Jie Yang Wan (偉安解癢丸) contains hidden drug ingredients

  [7-10-2024] The Food and Drug Administration is advising consumers not to purchase or use Vail-Bon Jie Yang Wan, a product promoted and sold for several skin conditions on various websites, including www.everymarket.com and possibly in some retail stores. …

  Distribution channels: Healthcare & Pharmaceuticals Industry