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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

The FDA Law Blog

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

The FDA Law Blog

These practical benefits are in marked contrast to molecular COVID-19 tests that are used for definitive diagnosis and are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected. Ironically, a recent FDA safety communication points to a potential way out of this dilemma.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

FDA 105
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Complete guide on pharmaceutical medical affairs

Viseven

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Transformational therapies demand a new mindset

pharmaphorum

Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. There are a number of drivers behind the need to rethink value evidence and value communication. Changes are afoot – what to look for.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology.