The FDA Law Blog

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. Please see detailed information in the attached flyer , including a link to register for our free webinar. When the public health emergency ends on May 11, 2023 , so do these exemptions. We hope you join us!

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Controlled Substances FDA 98

The FDA Law Blog

JUNE 10, 2024

Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00-3:30 pm ET.

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Controlled Substances 59

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.

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Labelling FDA 119

The FDA Law Blog

FEBRUARY 11, 2025

In addition, on Tuesday, February 18, Hyman, Phelps & McNamara will be co-hosting a webinar on the CMS final rule with Riparian LLC. The webinar will explore the legal and operational considerations for drug manufacturers. Once you register, youll receive instructions by email on how to access the webinar.

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The FDA Law Blog

APRIL 12, 2023

will present a webinar entitled “ Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C.

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FDA 52

Pharma Marketing Network

APRIL 27, 2025

Capturing contact data through gated content, webinars, or opt-in emails enables ongoing engagement and clinical education. Regulatory Constraints HIPAA, GDPR, and FDA guidelines shape how leads are collected, stored, and contacted. Webinars, white papers, and CME resources are particularly effective.

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Health and Personal Care Stores HIPAA FDA Insurance 52

The FDA Law Blog

SEPTEMBER 13, 2022

s Deborah Livornese will be a panelist for FDAnews’ September 15, 2022 webinar titled “Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis”. Aspirational only title notwithstanding, you can find more information about the webinar and registration at FDAnews and use code VIP20 for a 20% discount.

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FDA 40

The FDA Law Blog

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. To register for this insightful webinar, visit AMCP Learn. This afternoon Hyman, Phelps & McNamara, P.C.

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Pharma Marketing Network

APRIL 2, 2025

From webinars and social media to AI-powered chatbots and targeted programmatic ads, digital touchpoints now define the majority of brand interactions. Multichannel integrationacross email, webinars, virtual conferences, search, social media, and mobile appsis key.

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Communication FDA 64

The FDA Law Blog

MAY 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests ( LDTs ). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs.

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The FDA Law Blog

MAY 3, 2023

HP&M”) invites you to join Director Larry Houck for a free webinar demystifying DEA inspections by providing an understanding of controlled substance accountability audits, the importance of conducting mirror reviews and mock DEA-style internal inspections. The webinar will share additional valuable inspection tips.

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Controlled Substances 52

Pharma Marketing Network

MARCH 8, 2025

It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. Lead Generation: Captures email sign-ups, webinar registrations, and telehealth inquiries. Avoid misleading claims Always align with FDA-approved language.

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HIPAA FDA Communication 59

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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pharmaphorum

SEPTEMBER 28, 2020

pharmaphorum’s Behavioural insights into haem/onc clinical decision making webinar, in association with Medscape, showed that this can negatively impact physicians’ confidence as they try and keep on top of information about an array of treatment options. Data from the US cited during the webinar showed a five-year survival rate of 34.2%

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The FDA Law Blog

MAY 22, 2023

HP&M”) invites you to join Director Larry Houck for a free webinar demystifying DEA inspections by providing an understanding of controlled substance accountability audits, the importance of conducting mirror reviews, and mock DEA-style internal inspections. Hyman, Phelps & McNamara, P.C. (“HP&M”)

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Controlled Substances 40

Pharma Marketing Network

MARCH 6, 2025

Follow FDA and HIPAA Guidelines No misleading claims Every medical statement must be backed by FDA-approved data. Share industry reports, research papers, and professional webinars. Promote webinars and thought leadership content. Use interactive polls and live Q&As to boost engagement.

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ISPE

MAY 22, 2023

The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA.

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Communication FDA 98

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. Consequently, because “it calls into question the data integrity of the entire file”, FDA asserted that is unable to rely on the data to grant marketing authorisation.

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FDA Communication 104

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. Offer incentives like exclusive research reports or webinar invites. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations.

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Pharma Marketing Network

JUNE 3, 2025

Today, digital-first strategies dominate, emphasizing email marketing, display ads, social media, webinars, and branded content. All CTAs should align with FDA regulations and be vetted by MLR (Medical, Legal, Regulatory) teams. How can CTAs remain compliant with FDA guidelines? Learn more.” What makes a good CTA for HCPs?

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Dosage FDA Communication 59

Pharma Marketing Network

NOVEMBER 24, 2024

Use medical conferences, webinars, and educational content to connect with HCPs authentically. Always adhere to FDA guidelines and include clear disclaimers in campaigns. Adhering to FDA guidelines, consulting legal experts, and incorporating disclaimers ensure compliance. Building trust is vital. Non-compliance can cost dearly.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

pharmaphorum

FEBRUARY 1, 2022

This webinar will also explore: (two or three bullet points). He has worked on Visensia, the world’s first FDA-approved multivariate patient monitoring system, and the SEND system, which is now used to monitor 20,000 patients each month in the NHS. Designing and generating a synthetic control arm. Evaluating and selecting data sources.

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FDA 104

BioPharm

AUGUST 8, 2023

Webinar Date/Time: Wed, Sep 27, 2023 11:00 AM EDT

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FDA 52

Pharma Marketing Network

MARCH 5, 2025

So how can pharma brands maximize their return on investment (ROI) while ensuring compliance with FDA and HIPAA regulations ? blogs or webinars). From FDA guidelines to Googles ad policies , failure to comply can result in ad disapprovals, fines, or reputational damage. How can pharma brands improve PPC targeting for HCPs?

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Pharma Marketing Network

MAY 18, 2025

Certainly, navigating FDA, EMA, or OPDP guidelines can be daunting. Tools like virtual eDetailing, interactive webinars, and AI-driven email automation allow brands to stay relevant without disrupting clinical workflows. FAQs Is digital marketing in pharma compliant with FDA regulations? Can pharma use social media safely?

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FDA Communication 52

Pharma Marketing Network

NOVEMBER 15, 2024

Ensure you stay compliant with FDA guidelines by including necessary disclaimers. Yes, especially for reaching specific demographics or promoting content like webinars. Both are critical components of effective social media marketing strategies. Ensure all medical claims are backed by evidence and include necessary disclaimers.

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FDA 52

Pharma Marketing Network

MAY 18, 2025

Certainly, navigating FDA, EMA, or OPDP guidelines can be daunting. Tools like virtual eDetailing, interactive webinars, and AI-driven email automation allow brands to stay relevant without disrupting clinical workflows. FAQs Is digital marketing in pharma compliant with FDA regulations? Can pharma use social media safely?

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FDA Communication 52

Pharma Marketing Network

MARCH 19, 2025

Social media analytics should always align with FDA, HIPAA, and GDPR regulations to protect patient privacy and ensure ethical marketing practices. Pharma brands must ensure their social media practices follow FDA, HIPAA, and GDPR regulations to maintain ethical marketing standards.

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European Pharmaceutical Review

APRIL 4, 2025

One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). Additionally, FDA readiness has been established through a proactive external assessment of quality systems. Any identified gaps have been addressed.

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Dosage Packaging FDA Communication 64

Pharma Marketing Network

APRIL 4, 2025

Patient support platforms may include features that allow users to invite others to educational webinars or support communities. Every message, endorsement, or testimonial must meet FDA, FTC, and local privacy regulations. All referral activities must follow FDA, FTC, and HIPAA guidelines, with full transparency and consent.

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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.

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Controlled Substances FDA Documentation Labelling 59

Pharma Marketing Network

MARCH 16, 2025

They must be highly targeted, compliant with FDA and HIPAA guidelines, and designed to generate meaningful interactions rather than just impressions. webinar sign-ups or prescription inquiries). Lead generation (measured by webinar sign-ups or whitepaper downloads). Cost-Per-Click (CPC) to manage ad spend efficiently.

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HIPAA FDA 52

pharmaphorum

AUGUST 24, 2022

The Food and Drug Administration’s (FDA) draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials , recommends sponsors develop and submit a race and ethnicity diversity plan early in clinical development. Community-led.

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Documentation FDA 111

Pharma Marketing Network

APRIL 25, 2025

Hosting webinars, funding support groups, or developing resource-rich microsites can enable patients to become informed advocates. Strict Regulatory Environment The FDA, PhRMA Code, and global counterparts like EMA place tight constraints on what can be promoted and how. Is Referral Marketing compliant with FDA regulations?

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HIPAA FDA 52

PQA

AUGUST 15, 2022

The PQA Quality Essentials Webinar?provides?education PQA’s June 16, 2022, Quality Essentials Webinar featured Rachel Digmann, PharmD, Senior Director of Performance Measurement, and Ben Shirley, CPHQ, Director of Performance Measurement, at PQA. education on the fundamentals of quality measurement, which?is?important important for?effective

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FDA 52

Pharma Marketing Network

FEBRUARY 27, 2025

Blogs, whitepapers, webinars, and infographics can help position your brand as a trusted authority. Using FDA-approved messaging and ensuring transparent disclaimers are critical in avoiding regulatory issues. Brands must adhere to HIPAA, FDA, and GDPR guidelines when collecting and using patient data.

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Pharma Marketing Network

MAY 7, 2025

Segmentation models are becoming more sophisticated, and content delivery must be agile to adapt to diverse channelsincluding email, programmatic media, webinars, and digital detailing. Marketing teams must collaborate closely with legal and medical affairs to ensure all messaging adheres to FDA and global promotional standards.

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FDA 52