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PSUSA outcome published: PSUSA/00000110/202601

PSUSA outcome published: PSUSA/00011084/202603

Good machine learning practice for medical device development

10 guiding principles that can inform the development of good machine learning practice (GMLP).

AI Airlock Phase 3 application

What the National Commission’s recommendations mean for you

How new recommendations could make healthcare AI safer, clearer and fairer for patients, professionals, providers and developers across the UK.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October

PSUSA outcome published: PSUSA/00002550/202601

Renewing marketing authorisations for medicines

How to renew marketing authorisations for products granted through different routes and at different times.

Class II drug recall: MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ (Shantou Qiwei Industrial Co., Ltd)

cGMP Deviations Recall D-0854-2026; status Ongoing; distribution: CA only.

Class II drug recall: Reliable-1 Laboratories Lubricating Tears (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0859-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Clear Eyes Redness Relief (Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company)

Lack of Assurance of Sterility Recall D-0870-2026; status Ongoing; distribution: Nationwide in the USA..

Class II drug recall: Walgreens Lubricant Eye Drops (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0857-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Major LubriFresh P.M. Nighttime Ointment (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0861-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Exenatide Injection (Amneal Pharmaceuticals Of New York, Llc)

Defective Delivery System: Possibility of no medication in the prefilled pen. Recall D-0868-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Reliable -1 Laboratories (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0856-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Lubricant Eye Drops-Cameron Pharmaceuticals (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0862-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0855-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0860-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Dopamine HCl Inj. (Pfizer)

Lack of Assurance of Sterility Recall D-0853-2026; status Ongoing; distribution: US Nationwide..

Class II drug recall: Chlorthalidone Tablets (Inventia Healthcare Limited)

Failed Dissolution Specifications Recall D-0852-2026; status Ongoing; distribution: U.S. Nationwide.

Class II drug recall: Lidocaine Ointment USP (Sun Pharma /Taro)

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). Recall D-0848-2026; status Ongoing; distribution: Nationwide in the USA.

Class II drug recall: Fluphenazine HCl Elixir (Safecor Health, Llc)

Failed Stability Specifications Recall D-0841-2026; status Ongoing; distribution: Nationwide in the USA..

Class I drug recall: Thyroid Tablets (Vitruvias Therapeutics Inc)

Superpotent Drug Recall D-0866-2026; status Ongoing; distribution: US Nationwide..

Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs.

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method and on regulatory submissions to FDA for such products. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The guidance announced in this notice finalizes the draft guidance of the same title dated October 18, 2024.

Class I drug recall: 0.9% Sodium Chloride Injection (B Braun Medical Inc)

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene Recall D-0869-2026; status Ongoing; distribution: Nationwide within the United States.

Class I drug recall: Dextrose Injection (Baxter Healthcare Corporation)

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. Recall D-0850-2026; status Ongoing; distribution: U.S. Nationwide..

Class I drug recall: Epinephrine Injection (American Regent, Inc.)

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. Recall D-0865-2026; status Ongoing; distribution: Nationwide within the U.S.A.

Class II drug recall: fentaNYL Citrate (Ourpharma Llc)

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). Recall D-0864-2026; status Ongoing; distribution: Nationwide within the U.S.

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.