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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 ).
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.
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!
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.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
A recent draft from the FDA provides valuable insight. In this exclusive webinar, Dr. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?
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.
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.
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.
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.
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.
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.
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.
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. Thus, FDA funding could be what is needed on this front, says Cudkowicz.
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.
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.
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%
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.
To build strong HCP networks: Host webinars and conferences : Share new research and treatment insights. Overcoming Challenges in Marketing Networks While the benefits of marketing networks are clear, challenges abound: Regulatory constraints : Ensure compliance with FDA and EMA guidelines. Ensure faster adoption of new therapies.
In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr.
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”)
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.
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.
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.
In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr.
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.
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.
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.
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.
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?
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.
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.
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.
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.
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.
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
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.
Pharma brands are integrating multiple touchpoints, from email and webinars to social media and HCP portals. Build campaigns that prioritize transparency while remaining compliant with FDA and EMA guidelines. Pharma brands that produce insightful blogs, whitepapers, and webinars attract both HCPs and patients.
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!
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.
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.
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.
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 ).
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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