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The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.
If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. Rewind to March of 2020, and pharma companies were facing a communication crisis. The crisis that changed everything.
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.
The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.
Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. We will release exciting details of our upcoming webinar addressing telemedicine soon. Stay tuned.
Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? Click-Through Rate (CTR) : Are recipients engaging with links?
and management communication strategy. In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. ™ hackathons were established, and the ISPE Factory of the Year (FOYA) award category was created.
Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.
Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE.
Being aware of pharmaceutical advertising laws, fair balance requirements, and off-label promotion restrictions will prevent costly compliance mistakes. Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness. Organizations like the FDA (U.S.),
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
While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The materials from this webinar are still available on FDAs website ( here ). Since the new administration took office, however, the webinar page has been taken down from FDAs website.
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