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.

Labelling 64

Labelling Communication Documentation 64

pharmaphorum

SEPTEMBER 23, 2022

It was already unlikely that the two companies would get a positive outcome from the Oncologic Drugs Advisory Committee (ODAC), after damning assessments by the FDA reviewer in documents published ahead of yesterday’s decisions, but shares in both firms still slumped after the verdicts emerged.

Documentation 52

Documentation 52

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. FDA recommends this be based on the November 2024 expected employee filings.

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Pharmacy Technician Documentation Communication Packaging 45

Big Molecule Watch

OCTOBER 2, 2023

Fourth, the government argued that the claims are not ripe because any harm that would affect AbbVie would not occur until 2026, and the alleged injuries are dependent on circumstances that may or may not occur.

Drug Pricing 64

Drug Pricing Documentation 64

Viseven

SEPTEMBER 18, 2024

By the end of 2026, the company will be able to analyze two million genomes. Marketing teams can easily collaborate with other departments and clients, sharing documents and files to create compelling campaigns. This innovative approach has brought more than 40 successful drug discovery projects to AstraZeneca.

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Communication Vaccines Pharmaceutical Companies Pharmaceutical Companies 52

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Therefore, the NHC requests that CMS offer more clarity into exactly how it will exclude QALY-based metrics from analysis of certain evidence in value-based decisions.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

Putting Patients First Blog

SEPTEMBER 3, 2024

The NHC observed significant frustration with the portal during the IPAY 2026 process, where many participants found it difficult to navigate or understand how to properly submit their input. However, the success of this format heavily depends on the overall approachability of the ICR portal – how intuitive and user-friendly it is.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Putting Patients First Blog

JANUARY 10, 2024

Pharmacy and Therapeutics (P&T) Committee Standards: The NHC supports the inclusion of a consumer representative in P&T committees starting January 1, 2026, ensuring patient perspectives are considered in formulary decisions, decisions with patient needs and preferences. Retrieved from https ://w ww. Retrieved from https ://ww w.ac

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Diabetes 40

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”. 1 and go into effect in 2026.

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Biosimilars Drug Pricing Documentation Labelling 130

Putting Patients First Blog

FEBRUARY 11, 2025

Overarching Comments The NHC acknowledges CMS efforts to implement meaningful policy updates in CY 2026 to advance equity, affordability, and access to high-value care for Medicare beneficiaries. Equally critical is clear and accessible communication with beneficiaries.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Communication Documentation Hospitals 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

Documentation 64

Documentation Drug Development 64

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks.

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Documentation Labelling Method Validation Communication 71