Pharma Marketing Network

MARCH 31, 2025

Introduction Pharmaceutical marketing is entering a new era in 2025, driven by rapid advancements in technology, evolving patient expectations, and tighter compliance demands. Similarly, patients benefit from communications that resonate with their condition, treatment stage, and lifestyle.

HIPAA 52

HIPAA Communication Labelling 52

FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 11] In the context of an LDT, it is unclear what FDA will include within the scope of “labeling” and what types of communications will be considered “claims.”

Labelling 64

Labelling Communication Documentation 64

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Here are some of the top regulatory developments from 2024.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e., Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2.

Labelling 64

Labelling Communication 64

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

FDA Law Blog: Biosimilars

JULY 9, 2024

If FDA determines that a waiver will be issued, it may consider public communications about the decision. Since it is only the submission of the plan that is required by law, how, if at all, will FDA communicate that a plan does not meet the requirements for submission? Some unanswered questions remain.

Drug Development 59

Drug Development Communication Documentation Labelling 59

ID Stewardship

DECEMBER 11, 2024

With Twitter changing to X in mid-2023 and subsequently in the end of 2024 many folks from the IDtwitter community moving over to Bluesky, the game is certainly ever-changing. I wonder if this will cause us to be more fragmented as a group in 2025 and if Bluesky will really have sticking power. Mastodon sure did not.

HIV Treatment and Prevention Agents 145

HIV Treatment and Prevention Agents Labelling Hospitals Communication 145