The FDA Law Blog

SEPTEMBER 22, 2024

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.

FDA 64

FDA Communication Labelling 64

pharmaphorum

OCTOBER 27, 2022

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.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

pharmaphorum

OCTOBER 12, 2018

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.

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Communication Labelling Patient Care FDA 52

The FDA Law Blog

FEBRUARY 27, 2023

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.

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Controlled Substances FDA Documentation Communication 59

Pharma Marketing Network

FEBRUARY 19, 2025

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?

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HIPAA FDA Communication Labelling 72

ISPE

JULY 19, 2023

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.

Documentation 98

Documentation FDA Communication Labelling 98

The FDA Law Blog

OCTOBER 10, 2023

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.

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FDA Documentation Labelling Communication 45