Pharmaceutical Quality Resources
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
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Guidance: The Innovative Devices Access Pathway (IDAP)
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
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Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) -
Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate Nonpareils
Weaver Nut Company, Inc. is recalling the following chocolate products with specific lot codes, due to potential undeclared milk allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume the impacted products an -
Medtech Products Inc. Issues Nationwide Recall of Little Remedies® Honey Cough Syrup Due to Microbial Contamination
June 17, 2025—Medtech Products Inc., a Prestige Consumer Healthcare Inc. company (“Medtech” or “Company”), is voluntarily recalling five lots of Little Remedies® Honey Cough Syrup (the “Product”) due to the presence of Bacillus cereus and loss of shelf-stability. Bacillus cereus (B. cereus) can cau -
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension. -
IXCHIQ Chikungunya vaccine: temporary suspension in people aged 65 years or older
The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure while the MHRA conducts a safety review. The IXCHIQ vaccine will be available on the UK market from 18 June 2025.
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Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.
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Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics
The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal. -
Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation. -
Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
Blood Products Administration Sets recalled due to incorrect assembly. Use may lead to administration of unfiltered blood or delays in therapy. -
Patient Listening Session Summaries
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 summaries for Patient-led sessions.