2025 Communication Labelling 
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.
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.”
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Putting Patients First Blog
APRIL 8, 2025
NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. 9 Labeling materials should describe how the technology works, its intended use, known limitations, and the circumstances under which human oversight is recommended.
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.
Putting Patients First Blog
APRIL 7, 2025
NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. Sponsors must document how AI- generated safety signals are prioritized, validated, and communicated to regulators and health care providers.
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.
Pharmaceutical Technology
DECEMBER 22, 2022
The new joint procedure will launch in Q1 2025 for oncology medicines and other advanced therapy medicinal products and extend to orphan drugs in 2028. However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations.
Expert insights. Personalized for you.
52 
Let's personalize your content