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 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

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

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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FDA 59

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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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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FDA Research Laboratories Documentation 69

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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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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HIPAA FDA 52

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

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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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

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

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

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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HIPAA FDA 52

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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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

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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HIPAA Pharmaceutical Companies Pharmaceutical Companies 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.

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Controlled Substances FDA Documentation Communication 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

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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HIPAA FDA Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 6, 2023

Secured by default When the FDA determines a manufacturer violated manufacturing practices, including ALCOA, they issue a Warning Letter. A software application must produce an audit trail to be compliant per FDA regulations (21 CFR Part 11) and EU Regulation (EU Annex 11, Section 12). Register Now!

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Communication Pharmaceutical Companies Pharmaceutical Companies FDA 97

The FDA Law Blog

JANUARY 22, 2024

OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year. Drug Supply Chain. Clinical Trials.

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Compounding FDA Communication 59

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

Pharma Marketing Network

NOVEMBER 1, 2024

Attending Conferences and Webinars Conferences and webinars provide an immersive learning experience, allowing you to explore new trends and network with other professionals. Engaging with experts on social media or attending their webinars can provide valuable insights into emerging trends and best practices.

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FDA 52

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 ).

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HIPAA FDA Communication Labelling 72

pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals FDA 98

Pharmaceutical Technology

NOVEMBER 30, 2022

In the first official regulatory guidance on this matter released in 2008, the Food and Drug Administration (FDA) established CCIT as a requirement, closely tying it to the concept of microbiological integrity. Free Webinar. Webinar: Why and how to replace Dye Ingress Test by deterministic CCIT methods. Wallis and Futuna.

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Packaging FDA Communication 52

pharmaphorum

AUGUST 3, 2022

Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Conference Forum webinar. Greater standardisation of data fields and codes, as suggested by the FDA, could help to shift this dial, and ensure insights are not wasted.

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Cerner FDA 124

The Spirit Pharmacist

MAY 1, 2024

If looking for a primer on ST or want to dig deeper into the toxidrome you can check out this blog , webinar , or journal article I have on the subject. This is likely because psilocybin and psilocin lack the requisite pharmacologic activity to cause ST.

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Hospitals FDA 98

Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” The featured speaker was, Shabbir J.

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