Big Molecule Watch

JULY 22, 2024

On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. requesting data and documents regarding their business and business practices. OptumRx, Inc.;

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Independent Pharmacies Biosimilars Documentation Labelling 59

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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FDA Law Blog: Biosimilars

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FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024.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

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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Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

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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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Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. Sincerely, Randall L.

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RX Note

AUGUST 25, 2024

FDA requires the labels of all herbal supplements to include the complete list of ingredients and manufacturers must follow good manufacturing practices (GMP) to ensure that supplements are processed consistently and meet quality standards. Monitor therapy. Avoid in pregnancy.

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Diabetes Community Pharmacies Dosage Documentation 52

GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? Additional documents included each month.

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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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Immunity Immunization Vaccines Health and Personal Care Stores 40

FDA Law Blog: Biosimilars

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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Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

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Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

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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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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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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FDA Law Blog: Biosimilars

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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Labelling Documentation 59

Express Pharma

JANUARY 27, 2025

He emphasised that India currently holds the third position globally in pharmaceutical production volume and the fourteenth in value, achieving a remarkable $27 billion in pharmaceutical exports in 2024, signifying immense growth potential. The next session in the PULSE Series, Investigations and CAPA, is scheduled for February 02, 2025.

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FDA Law Blog: Biosimilars

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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Express Pharma

FEBRUARY 10, 2025

What are the top 3 biopharma trends that you have observed in 2024 with India as a focused region as well as looking at it locally? We’re really having the ability now in a much more regulated framework and environment about what we can say in the pharma industry has to be on label.

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FDA Law Blog: Biosimilars

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 Law Blog: Biosimilars

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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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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