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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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FDA backs pharmacist prescribing of Paxlovid for COVID

pharmaphorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. Now, in addition to doctors and providers, the FDA announced pharmacists with your medical information can prescribe Paxlovid to patients.

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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.

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FDA starts review of Sanofi, AZ antibody for RSV prevention

pharmaphorum

The clock has started ticking on the FDA’s review of Sanofi and AstraZeneca’s one-shot antibody to protect newborns and infants from respiratory syncytial virus (RSV), with a decision due in the third quarter – just in time for the 2023/24 RSV season.

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Excitement associated with FDA approval of Rinvoq in Crohn’s disease

Pharmaceutical Technology

On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.

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Compliance and the Pharmaceutical Sales Rep: Navigating the Regulatory Landscape

Contrarian Sales Techniques

Regulatory requirements such as HIPAA and FDA regulations are put in place to protect patient's safety and ensure that all sales and marketing efforts are compliant. It's not just about selling a product, it's about ensuring that all sales and marketing efforts are compliant and patient's safety is kept as a top priority.

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. FDA’s guidance on SaMD, CDSS, and other mobile applications does not contemplate the advent of generative AI technologies.