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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024.

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5 Instances Of Challenging Antibiotic Workflows

ID Stewardship

BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here. Authored By: Timothy P. Gauthier, Pharm.D., Well, maybe not. Products can impact stability.

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Getting Quality Supplements

The Thyroid Pharmacist

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 95 expiring in March 2024.)

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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’

pharmaphorum

The negotiations over the treaty are being hosted through the World Health Organization (WHO), with plans to officially adopt a binding agreement sealed by the United Nations health agency’s member countries in May 2024. The UN Special Rapporteur on contemporary forms of racism, E.

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T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth. billion in sales in 2019, increasing to $136.2

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Innovating for Individual Care: The Impact of USP on Personalized Medicine

Quality Matters

USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications. kristine.gates… Fri, 03/01/2024 - 14:45 Medicines Accessed via [link] on Sep 05, 2023. Markets and Markets, 2023.