The Pharmacist

JUNE 11, 2024

The Conservative Party has set out spending plans of £250m each year on Pharmacy First from 2027 to 2030, as it pledges to expand the service to include more conditions like acne and chest infections.

Documentation 89

Documentation 89

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.

Documentation 59

Documentation Communication 59

Putting Patients First Blog

JULY 2, 2024

Clarification on QALY Metrics The NHC appreciates CMS’ commitment to excluding Quality-Adjusted Life Years (QALYs) from the negotiation process as outlined in the 2027 draft guidance. Valuing life differently based on disability status, age, or other special populations is inappropriate.

Drug Pricing 52

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. Conclusion The NHC appreciates the opportunity to provide input on the IRA 2027 Drug Price Negotiation ICR.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. This guidance, when finalized, will replace the original version of this document finalized in 2017.

Medical Records 111

Medical Records Documentation 111

FDA Law Blog: Biosimilars

JUNE 8, 2023

It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

Communication 53

Communication Biosimilars Documentation 53

pharmaphorum

OCTOBER 1, 2022

The latest judgments relate to an attempt by Chinese drugmaker HEC Pharma to bring a generic version of fingolimod to market in the US, and Novartis defense of the 9,187, 405 patent which expires in December 2027.

Documentation 52

Documentation 52