pharmaphorum

MAY 20, 2024

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th July @ 07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST.

Labelling 119

Labelling FDA 119

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 ).

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FDA Communication Labelling 64

Pharma Marketing Network

MARCH 18, 2025

Conversion Rate: Tracks how many users complete a desired action, such as signing up for a webinar or downloading whitepapers. Avoiding misleading claims or unapproved off-label promotions. Offer incentives like exclusive research reports or webinar invites. How can pharma marketers ensure PPC ad compliance?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

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.

Communication 52

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. The only schedule III-V narcotic drug that is currently approved by the FDA for OUD treatment is buprenorphine.

Controlled Substances 59

Controlled Substances FDA Documentation Communication 59

Pharma Marketing Network

FEBRUARY 19, 2025

Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging. FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. Ideal: 2-5% CTR ).

HIPAA 72

HIPAA FDA Communication Labelling 72

The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. For instance, FDA highlights risks associated with everyday activities (e.g.,

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FDA Documentation Labelling Communication 45