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.

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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NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 12 To this end, the NHC encourages the FDA to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.

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 The draft guidance indicates that this timetable will be announced by September 30, 2025.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

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EMCrit Project

JUNE 23, 2025

Most medical documentation is polluted with it, for want of using the persons actual name. Published on June 23, 2025. Accessed on June 24th 2025. CME Review Original Release: June 23, 2025 Date of Most Recent Review: June 23, 2025 Termination Date: Jul 1, 2027 You finished the cast, Now Join EMCrit! EMCrit Blog.

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Hospitals Labelling Medical Schools Documentation 86

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.

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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.

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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.

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Dosage Drug Development Documentation Biosimilars 52

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. §

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Labelling Communication Documentation 64

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).

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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Labelling Documentation 59

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.

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Labelling Documentation 52

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

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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.

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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.

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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.

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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.

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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

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