The FDA Law Blog

FEBRUARY 28, 2024

FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. The next document in the docket is a letter from Dr. Marks referring to an upcoming October 2, 2023, joint (virtual) meeting with CDER and Oncopeptides. Tobolowsky & Michelle L. On August 4, 2023, Oncopeptides submitted its appeal.

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pharmaphorum

MARCH 8, 2022

The company didn’t conduct a conference call to discuss the findings, but took the unusual step of publishing a frequency asked questions (FAQ) document on the study, headlined with a non-committal statement about whether the data were “clinically meaningful.”

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Chemotherapy Documentation Labelling 52

pharmaphorum

JANUARY 21, 2021

It can be prescribed in combination with methotrexate or as a monotherapy if the patient isn’t able to receive methotrexate, according to the final appraisal document (FAD). Having moderate disease on the label means that thousands more patients will be eligible for treatment with Jyseleca, according to Gilead and Galapagos.

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European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2024 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. British Herbal Medicine Association.

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The FDA Law Blog

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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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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Immunization Vaccines Health and Personal Care Stores Labelling 40

The FDA Law Blog

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents.

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The FDA Law Blog

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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Documentation Labelling FDA 105

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

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The FDA Law Blog

JANUARY 14, 2025

A brief review of FDA actions (or lack thereof) in 2024 shows that FDA failed to meet any of the statutory deadlines set by MoCRA. MoCRA includes several self-executing requirements, such as registration and product listing, adverse event reporting requirements and labeling for adverse event reporting. Just on the cusp of 2024, on Dec.

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FDA Labelling Documentation 59

The FDA Law Blog

JANUARY 9, 2025

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

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FDA Documentation Labelling 105

The FDA Law Blog

JANUARY 2, 2025

FDA received more than 400 comments, resulting in a final rule published on December 27, 2024, covering more than 100 pages. 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. The final rule maintains the concept of the proposed rule.

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FDA Labelling Documentation 52

The FDA Law Blog

NOVEMBER 7, 2024

As an example, we filed a 513(g) request in December 2024. 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.

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The FDA Law Blog

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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FDA Documentation Labelling Hospitals 104