• What’s New for Biologics
    Friday, July 18, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Latest news from the Center for Biologics Evaluation and Research
  • FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
    Friday, July 18, 2025 from Food and Drug Administration--Press Releases
    FDA is announcing today it has placed Elevidys and certain Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold due to new safety concerns that the study participants are or would be...
  • International Activities
    Friday, July 18, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.
  • Regenerative Medicine Advanced Therapy Designation
    Friday, July 18, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.
  • Biologics Electronic Reading Room (eFOIA)
    Thursday, July 17, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
  • Recently Issued Guidance Documents
    Thursday, July 17, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page lists Recently Issued CBER and Cross-Center Guidance Documents.
  • Clinical Guidances
    Thursday, July 17, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page lists Clinical Guidance documents.
  • SHINGRIX
    Thursday, July 17, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This is the main page for the CBER SHINGRIX.
  • Chetak LLC Group Recalls Product Because of Possible Health Risk
    Wednesday, July 16, 2025 from Food and Drug Administration--Recalls
    Are recalling Frozen ‘Deep Sprouted Mat(Moth) 16 oz. and Deep Sprouted Moong 16oz. because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infection in young children,...
  • MNEXSPIKE
    Wednesday, July 16, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any...
  • FDA to Revoke 52 Obsolete Standards of Identity for Food Products
    Wednesday, July 16, 2025 from Food and Drug Administration--Press Releases
    FDA is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary.
  • Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects
    Wednesday, July 16, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects
  • Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen
    Wednesday, July 16, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This is the draft guidance Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen
  • Krasniy Oktyabr Inc. USA Issues Alert on Eviscerate Dry Salted Vobla “Aral Silver”
    Tuesday, July 15, 2025 from Food and Drug Administration--Recalls
    KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.
  • Patient Engagement Collaborative
    Tuesday, July 15, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.
  • Update – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection
    Tuesday, July 15, 2025 from Food and Drug Administration--Recalls
    Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials...
  • Blood Guidances
    Tuesday, July 15, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page contains a listing of Blood Guidances guidances.
  • BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies
    Tuesday, July 15, 2025 from Food and Drug Administration--Recalls
    BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled...
  • FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
    Tuesday, July 15, 2025 from Food and Drug Administration--Press Releases
    FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
  • World Market Recalls Emek Spread Pistachio Cacao Cream with Kadayif Due to Salmonella Contamination
    Monday, July 14, 2025 from Food and Drug Administration--Recalls
    World Market is recalling EMEK SPREAD PISTACHIO CACAO CREAM WITH KADAYIF, 9.7oz, Best Before: April 01, 2027, Batch Number: 250401 due to a potential contamination of Salmonella. Salmonella is an organism which can cause serious and...
  • YoCrunch® Products Voluntarily Recalled by Danone U.S. Due to Potential Presence of Plastic Pieces in Dome Topper
    Monday, July 14, 2025 from Food and Drug Administration--Recalls
    Danone U.S. is voluntarily recalling YoCrunch® products sold at retail stores nationwide due to the potential presence of plastic pieces in the dome topper. If consumed, the plastic pieces could potentially cause a choking response. The...
  • Jalux Americas, Inc. (dba J.sweets) Issues Allergy Alert on Undeclared Tree Nuts and Milk in L’espoir Brand Cookies
    Monday, July 14, 2025 from Food and Drug Administration--Recalls
    July 14, 2025, Jalux Americas, Inc.(dba J.sweets) of El Segundo, CA is recalling 32 units of L’espoir Brand L’espoir cookies and 28 units of L’espoir Brand Drycapot cookies, because they may contain the following undeclared allergens: in...
  • Patient Listening Session Summaries
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts...
  • Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement - 06/14/2022
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This is the CBER Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement.
  • Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.
  • Vaccines and Related Biological Products Advisory Committee May 22, 2025 Meeting Announcement - 05/22/2025
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    On May 22, 2025, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2025-2026 Formula for COVID-19 vaccines.
  • 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This is the main page for the 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).
  • Meeting Materials, Vaccines and Related Biological Products Advisory Committee
    Monday, July 14, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee
  • FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
    Monday, July 14, 2025 from Food and Drug Administration--Press Releases
    Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing...
  • Updated Release: Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
    Friday, July 11, 2025 from Food and Drug Administration--Recalls
    Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of...
  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
    Friday, July 11, 2025 from Food and Drug Administration--Recalls
    Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S....
  • SPIKEVAX
    Friday, July 11, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    COVID19 Vaccine, mRNA
  • LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk
    Friday, July 11, 2025 from Food and Drug Administration--Recalls
    LLK TRADING INC. of Linden, NJ, is recalling its 200g packages of “Needle Mushrooms” because it has the potential to be contaminated with Listeria monocytogenes
  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
    Thursday, July 10, 2025 from Food and Drug Administration--Recalls
    Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of...
  • Safety & Availability (Biologics)
    Thursday, July 10, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Important information about the safety and availability of biological products.
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom " Because of Possible Listeria Monocytogenes Contamination
    Thursday, July 10, 2025 from Food and Drug Administration--Recalls
    Wiet Peeters Farm Products Limited of Charing Cross Ontario, Canada is recalling its Aunt Mid’s Fresh Sliced Mushrooms 227g , Peeters Mushroom Farm Cremini Sliced 227g and Peeters Mushroom Farm Thick Slice Mushroom 10lb cardboard because...
  • A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
    Thursday, July 10, 2025 from Food and Drug Administration--Press Releases
    Statement from Commissioner Makary:100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
  • FDA Embraces Radical Transparency by Publishing Complete Response Letters
    Thursday, July 10, 2025 from Food and Drug Administration--Press Releases
    The FDA today published more than 200 decision letters, known as complete response letters (CRLs).
  • NATCO Pharma Limited - 6/19/2025
    Thursday, July 10, 2025 from ORA Reading Room RSS Feed
    NATCO Pharma Limited - 6/19/2025. Country: India. Record Type: 483
  • FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
    Wednesday, July 9, 2025 from Food and Drug Administration--Press Releases
    The U.S. Food and Drug Administration encourages industry leaders involved in manufacturing and distribution of infant formula, baby foods, and foods intended for children to streamline and enhance product recall communications.
  • Sun Pharmaceutical Industries Ltd. - 6/13/2025
    Wednesday, July 9, 2025 from ORA Reading Room RSS Feed
    Sun Pharmaceutical Industries Ltd. Country: India. Record Type: 483
  • Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error
    Tuesday, July 8, 2025 from Food and Drug Administration--Recalls
    Mondelēz Global LLC announced today a voluntary recall of four carton sizes of RITZ Peanut Butter Cracker Sandwiches (8-pack, 20-pack, and 40pack cartons of RITZ Peanut Butter Cracker Sandwiches, as well as the 20-pack RITZ Filled...
  • Natureen International Inc. Recalls Wei-Chuan Dried Black Fungus Slice (2.5oz) Because of Possible Health Risk
    Tuesday, July 8, 2025 from Food and Drug Administration--Recalls
    Natureen International Inc. of Walnut, CA is recalling 244 bags of Wei-Chuan Dried Black Fungus Slice (2.5oz / bag), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal...
  • Sheehan Brothers Vending Issues a Voluntary Recall Due to an Undeclared Sesame Allergen
    Tuesday, July 8, 2025 from Food and Drug Administration--Recalls
    Springfield, Ohio (July 8, 2025)- Sheehan Brothers Vending is recalling its Cheeseburgers, Spicy Chicken Sandwich, Italian Mini Subs, Pepperoni Pizza Sub, Chili Cheese Coney and BBQ Riblet w/coleslaw due to an undeclared Sesame allergen....
  • CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk
    Tuesday, July 8, 2025 from Food and Drug Administration--Recalls
    CHS Inc. is voluntarily recalling seven tons of Payback® Champion Lamb Text B30 with Power Booster due to potentially elevated levels of copper. Symptoms of copper toxicity in sheep include lethargy and anemia, grinding of teeth, thirst,...
  • FDA 483, dated June 11, 2008, (9 pages)
    Monday, June 30, 2025 from ORA Reading Room RSS Feed
    FDA 483, dated June 11, 2008, (9 pages)
  • Nirwana Foods Issues Allergy Alert on Undeclared Sulfites on Golden Raisin 28Oz Pouch Label
    Saturday, June 28, 2025 from Food and Drug Administration--Recalls
    Nirwana Foods of NJ is recalling its 28-ounce pouches Golden Raisin with lot number (24/351-2410) because they may contain undeclared sulfites. People who have allergies to sulfites run the risk of serious or life-threatening allergic...
  • FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
    Friday, June 27, 2025 from Food and Drug Administration--Press Releases
    FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
    Friday, June 27, 2025 from Food and Drug Administration--Recalls
    Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
    Thursday, June 26, 2025 from Food and Drug Administration--Recalls
    Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame.
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