FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Documentation Communication 59

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Putting Patients First Blog

SEPTEMBER 3, 2024

We strongly urge CMS to address these issues in the IPAY 2027 portal to ensure that all participants, regardless of their familiarity with technology or survey formats, can contribute their insights without unnecessary difficulty. Additionally, CMS must ensure that this technology is accessible for people with disabilities.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. Such changes are not limited to personal circumstances.

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Communication Biosimilars Documentation 53

Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

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Insurance Coverage and Processing Communication Documentation Diabetes 40

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. 110: Requirements for Coverage While the patient community is incredibly supportive of the Part D redesign and out-of-pocket cap, we understand plans will face higher liability moving forward.

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Drug Pricing Drug Development Documentation Communication 40