2025, Documentation and Labelling

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

Documentation

Documentation Labelling Drug Development

EMCrit 1:1 Nursing Podcast 002 – Post-Intubation Sedation (Pain, Agitation, & Delirium)

EMCrit Project

JUNE 16, 2025

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

Labelling

Labelling Hospitals Packaging Documentation

The rise of multimodal language models in drug development

European Pharmaceutical Review

JUNE 12, 2025

Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing.

Drug Development

Drug Development Documentation Labelling Diabetes

To 513(g) or not to 513(g)? That is the question

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

Documentation

Documentation Labelling

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices

Putting Patients First Blog

APRIL 8, 2025

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. 9 Labeling materials should describe how the technology works, its intended use, known limitations, and the circumstances under which human oversight is recommended.

Documentation

Documentation Labelling Communication

Finalizing the Quality Management System Regulation – A High Priority for End of 2023

FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. Dr. Shuren further elaborated that he hopes the final rule will be “out by the end of this year.”

Documentation

Documentation Labelling

Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults.

Documentation

Documentation Labelling Hospitals

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

APRIL 7, 2025

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier.

Documentation

Documentation Communication Pharmaceutical Manufacturing Labelling

The Rise of eSTAR for Medical Device De Novo Submissions

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. The draft guidance indicates that this timetable will be announced by September 30, 2025. These content elements precisely follow the De Novo request content described in 21 C.F.R.

Documentation

Documentation Labelling

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog: Biosimilars

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. If data are excluded because of data quality issues, the rationale and criteria for the exclusions should be documented in the DCP.

Documentation

Documentation Inpatient Labelling Hospitals

ICH Q6B for Analytics

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained.

Dosage

Dosage Drug Development Documentation Biosimilars

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. 803), Reporting of Corrections and Removals (21 C.F.R. §

Labelling

Labelling Communication Documentation

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. Would any such failure to meet DAP goals be reflected in labeling? 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

Drug Development

Drug Development Communication Documentation Labelling

To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food Allergens

FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

Documentation

Documentation Labelling

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Law Blog: Biosimilars

MAY 29, 2025

Javitt On May 8, 2025, FDA announced the successful completion of a generative artificial intelligence (AI) scientific review pilot program aimed at accelerating the review process and an aggressive timeline to rollout the use of AI tools across the Agency. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

Labelling

Labelling Documentation

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

LifeProNow

JUNE 4, 2025

June 02, 2025: “The U.S. Built within a high-security GovCloud environment, Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people.

Documentation

Documentation Labelling

FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.

Labelling

Labelling Documentation Packaging

FOPE and PharmaState Academy host session 13 of the PULSE series

Express Pharma

JANUARY 27, 2025

On January 5, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 13 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on materials, reference standards and vendor qualification.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Documentation Labelling

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

Immunity

Immunity Immunization Vaccines Health and Personal Care Stores

As 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing; Implementation of MoCRA Remains Much Slower Than Planned

FDA Law Blog: Biosimilars

JANUARY 14, 2025

MoCRA includes several self-executing requirements, such as registration and product listing, adverse event reporting requirements and labeling for adverse event reporting. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. FDAs report card therefore shows a big Incomplete.

Labelling

Labelling Documentation

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

FDA Law Blog: Biosimilars

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

Labelling

Labelling Documentation

AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

Documentation

Documentation Labelling Communication

India is rising from a CDMO perspective when it comes to biologics

Express Pharma

FEBRUARY 10, 2025

A lot of the work we’ve done in many years leading up to this and would be a big driver of 2025, is how do we really start seeing and feeling the impact of new technologies in the business? It will continue to be a trend in 2025. Some of these documents can take months to create with human medical writers.

Documentation

Documentation Drug Pricing Biosimilars Labelling

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

BioPharma Dive

JUNE 5, 2025

Published June 5, 2025 Amy Baxter Staff Reporter post share post print email license FDA Commissioner Martin Makary attends a Senate Appropriations Committee hearing May 22, 2025. Questions remain The FDA will plan to focus Elsa’s scope on administrative tasks such as summarizing documents and data extraction.

Drug Pricing

Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing

The Thyroid and Fertility

The Thyroid Pharmacist

MAY 12, 2025

25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial. Published 2025 Mar 20.

Immunity

Immunity Immunization Dosage Documentation

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog: Biosimilars

MAY 13, 2025

To date, neither FDA nor HHS has issued a guidance document describing circumstances in which the agencies will consistently grant waivers, as required under FDC Act 804(j)(2). Final Rule, Importation of Prescription Drugs , 85 Fed. 62,094, 62,097 (Oct. FDA has, however, set forth on its website a policy for personal importation.

Online Pharmacies

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog: Biosimilars

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. See United States v. Facteau , 89 F.4th

Labelling

Labelling HIPAA Documentation Immunity

Pharmacist Digest

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

EMCrit 1:1 Nursing Podcast 002 – Post-Intubation Sedation (Pain, Agitation, & Delirium)

Trending Sources

The rise of multimodal language models in drug development

To 513(g) or not to 513(g)? That is the question

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices

Finalizing the Quality Management System Regulation – A High Priority for End of 2023

Developing the EU’s first intestinal microbiota-based biologic

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

The Rise of eSTAR for Medical Device De Novo Submissions

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

ICH Q6B for Analytics

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food Allergens

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives

FOPE and PharmaState Academy host session 13 of the PULSE series

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

As 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing; Implementation of MoCRA Remains Much Slower Than Planned

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation

India is rising from a CDMO perspective when it comes to biologics

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

The Thyroid and Fertility

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

Stay Connected

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

EMCrit 1:1 Nursing Podcast 002 – Post-Intubation Sedation (Pain, Agitation, & Delirium)

Trending Sources

The rise of multimodal language models in drug development

To 513(g) or not to 513(g)? That is the question

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices

Finalizing the Quality Management System Regulation – A High Priority for End of 2023

Developing the EU’s first intestinal microbiota-based biologic

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

The Rise of eSTAR for Medical Device De Novo Submissions

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

ICH Q6B for Analytics

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food Allergens

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives

FOPE and PharmaState Academy host session 13 of the PULSE series

Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

As 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing; Implementation of MoCRA Remains Much Slower Than Planned

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation

India is rising from a CDMO perspective when it comes to biologics

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

The Thyroid and Fertility

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

Stay Connected

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01