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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law Blog: Biosimilars

CDRH’s long-standing definition of “valid scientific evidence” does not include opinions or beliefs. The potential consequences could be severe. Indeed, it explicitly excludes “random experiences” and “isolated case reports”, which seem to be the kinds of “evidence” that Kennedy is willing to rely upon when making his pronouncements.

FDA
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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog: Biosimilars

FDA provides definitions for the three datasets. Update practices and training of end users also need to be addressed. Data management practices should include how the manufacturer plans to obtain and use training, tuning, and test data to support each AI-DSF modification.

FDA
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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog: Biosimilars

The LDT Rule itself provides no operational guidance, but only a definition. This raises the question of whether and to what extent, if the rule moves forward, will FDA provide any tools to help laboratories as they seek to comply with these new requirements.

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Drug Channels News Roundup, February 2022: Mark Cuban vs. PBMs, MDs on Humira Biosimilars, States vs. PBMs, 340B Transparency, and Health Insurer Humor (?)

Drug Channels

I am pleased to report that this month’s Drug Channels news roundup was most definitely not written by ChatGPT. No promises about future articles. See our forecast to the right.)

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CMS Definition of “New Formulation” Upheld in Federal Court

FDA Law Blog: Biosimilars

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). All of these products are line extensions under CMS’s definition. Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist. times that of Medicaid ( $98 billion and $38.1

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Law Blog: Biosimilars

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.