2025, Documentation and Labelling

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

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

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

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 The draft guidance indicates that this timetable will be announced by September 30, 2025.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

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).

Immunization

Immunization Immunity Vaccines Health and Personal Care Stores

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

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

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

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 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

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

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

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

Pharmacist Digest

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

Developing the EU’s first intestinal microbiota-based biologic

Trending Sources

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

The Rise of eSTAR for Medical Device De Novo Submissions

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

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

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

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

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

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

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

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

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

Stay Connected

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

Developing the EU’s first intestinal microbiota-based biologic

Trending Sources

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

The Rise of eSTAR for Medical Device De Novo Submissions

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

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

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

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

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

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

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

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

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

Stay Connected

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