2025 Communication Labelling 
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.”
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.
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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.
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.
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.
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