FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

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Updated March 4, 2021

FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight

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According to the article:

"February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.  ...

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019, April 2020 and October 2020."

Read the full article:  FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

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FDA Issues Guidance On Continuous Manufacturing

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Updated June 25, 2023

The original link broke.

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Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry - FDA.gov (PDF)

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Quality Considerations for Continuous Manufacturing - Guidance for Industry

The guidance provides information regarding the FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files (DMFs), biologics license applications (BLAs), and nonapplication over-the-counter (OTC) products. Scientific principles described in the guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, the guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

Source:  Quality Considerations for Continuous Manufacturing - FDA Guidance for Industry (PDF)

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FDA’s Draft Quality Metrics Guidance, Version 2.0 - FDA Law Blog

Read the detailed analysis: FDA Law Blog: FDA’s Draft Quality Metrics Guidance, Version 2.0:

"In conclusion, the modifications made to the revised Draft Guidance are substantial (indeed, even the name of the document was changed). It will be interesting to see whether the quality metrics reporting program, a cornerstone of FDA’s framework for building quality into drug products, advances as planned.  The path for the program over the next few years is perilous, whether the agency seeks to finalize it via notice and comment rulemaking or simply via guidance."

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FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews

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Read the full article: FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews:

"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."

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View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability

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Technical Considerations for Additive Manufactured Devices - FDA.gov

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Recent Draft Medical Device Guidance Documents - FDA.gov:

"Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff" (PDF)

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The DSCSA Standards Guidance is here! « Ag/FDA Blog

Updated June 30, 2025

The link to the full article broke.

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Read the full article: The DSCSA Standards Guidance is here! « Ag/FDA Blog:

"With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance."

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Read the draft guidance:
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF - 85KB)

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Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

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Updated December 19, 2025

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Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry - FDA.gov

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FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies."

Source:

• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 359KB)

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FDA Releases ICH Draft Guideline on Elemental Impurities

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Updated February 14, 2021

Links broke in the original post.

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ICH HARMONISED GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - 

Q3D(R1) - ICH Consensus Guideline (PDF)

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US FDA Releases ICH Draft Guideline on Elemental Impurities - Outsourcing-Pharma.com:

"The guideline consists of three components: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE."

Follow this link to the guidance:  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - Q3D (pdf)

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Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

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FDA Law Blog: Recommendations of FDASIA Health IT Workgroup Accepted:

"The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to "post a report - within 18 months (or by January 2014) - that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."  FDASIA Section 618."

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FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

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Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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