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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.
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.”
They suggested that pharmacy-specific interventions should include targeted messaging and informative displays at the point of care, clearer labelling on medications to highlight their environmental impact and better access to pharmacy return schemes for unwanted medicines. 2025 Jan 20;15(1):e088066. doi: 10.1136/bmjopen-2024-088066.
Timely follow-up after hospital attendance and communication at transfers of care is therefore imperative Identifying patients through targeted searching of primary care databases is expected to be a way to review prescribing and revisit diagnosis. Accessed February 2025]. Accessed February 2025]. Accessed February 2025].
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.
Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.
Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.
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.
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.
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.
Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. By Charles D. Snow & Deborah L.
Timely follow-up after hospital attendance and communication at transfers of care is therefore imperative Identifying patients through targeted searching of primary care databases is expected to be a way to review prescribing and revisit diagnosis. Accessed February 2025]. Accessed February 2025]. Accessed February 2025].
LabelingLabeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A
On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. By Allyson B. Mullen & Jeffrey N.
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