Putting Patients First Blog

APRIL 8, 2025

9 Labeling materials should describe how the technology works, its intended use, known limitations, and the circumstances under which human oversight is recommended. Sponsors must also communicate how patient data are collected, processed, and used throughout the AI lifecycle, ensuring transparency and maintaining public confidence.

Documentation 52

Documentation Labelling Communication 52

FDA Law Blog: Biosimilars

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Per section 3305(e) of the Omnibus, FDA must provide an updated guidance document by December 2024. Loose Ends IDEs.

Documentation 105

Documentation Labelling Communication 105

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

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.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

The LDT-specific Product Codes are as follows: SCE : IVD offered as LDT, first marketed before May 6, 2024, and not modified beyond scope described in preamble to LDT Final Rule. Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e., By Steven J.

Labelling 64

Labelling Communication 64

Putting Patients First Blog

DECEMBER 5, 2024

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information (PDF) December 5, 2024 The Honorable Robert M. Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 1 (2024): e13896.

Labelling 40

Labelling Communication Mayo Clinic 40

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount?

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Would any such failure to meet DAP goals be reflected in labeling?

Drug Development 59

Drug Development Communication Documentation Labelling 59

ID Stewardship

DECEMBER 11, 2024

In this articlea selection of notable peer-reviewed publications from 2024 are provided. BCPS, BCIDP 2024 has been an interesting year forinfectious disease literature dissemination. Article Selection by: Bassam Ghanem, Pharm.D., MS, BCPS ArticleConstruction by: Timothy P. Gauthier, Pharm.D., Mastodon sure did not.

HIV Treatment and Prevention Agents 145

HIV Treatment and Prevention Agents Labelling Hospitals Communication 145

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. GlobalData predicts that Comirnaty’s sales will increase by more than 20% between 2024 and 2027. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

Vaccines 59

Vaccines Immunity Immunization Medical Schools 59

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Samsung Bioepis and Organon previously stated that Hadlima's interchangeability data should be ready in 2024. Please check your email to download the Report.

Biosimilars 104

Biosimilars Labelling Communication Hospitals 104

Pharmaceutical Technology

JANUARY 6, 2023

In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

European Pharmaceutical Review

JANUARY 20, 2025

Real-time label updates are also made possible by ePI, which means patients can always access the most up-to-date information on their medication, potentially enhancing patient safety. Moreover, fostering a culture of transparency and open communication will help build trust and encourage widespread adoption. Cited 2024Aug].

Communication 52

Communication Packaging Labelling Hospitals 52

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

Drug Development 64

Drug Development Communication Labelling 64