Kevin Faikish

⚗️ New from the Nolan Center - How can the US increase trust, transparency, and reliability in its medicines? From rooting out #counterfeit consumer drugs to shoring up vulnerabilities in the national security stockpile, visiting Senior Fellow Victor Suarez covers how to bolster the DSCSA and build overall resilience: https://lnkd.in/ekSvmPgV #biomanufacturing #biosecurity

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General Counsel, outside counsel, compliance executives, representatives of regulatory bodies and forensic practitioners met and discussed an array of issues at the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. Read some of our experts take-aways here: https://lnkd.in/gGhxaWag #EthicsAndCompliance #PharmaCongress2024 #RegulatoryExcellence

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Efficiency starts with a top-notch MLR submission. Set your PRC up for success with well-prepared materials and streamline your review process.

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🔍 DSCSA Compliance FAQ Series: FAQ #7 Do I need to track drugs that are under Emergency Use Authorizations? No, drugs falling under an Emergency Use Authorization are exempt from DSCSA requirements. Stay inormed about regulatory exemptions! Explore more here: https://hubs.ly/Q02wfRy00

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General Counsel, outside counsel, compliance executives, representatives of regulatory bodies, and forensic practitioners met to discuss an array of issues at the 2024 Pharmaceutical Compliance Congress. See what our experts thought were some of the key takeaways: https://lnkd.in/gPwAQf39 #lifesciences #healthcarecompliance #healthequity #compliance

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FDA's final rule on laboratory developed tests will take effect on July 5, 2024, but FDA identified several new enforcement discretion policies for specific types of LDTs in the preamble to the final rule. Read more in our Law360 article. #LDTs #wearemorganlewis Dennis Gucciardo

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Check out our recent case study, where Allucent expert, Zachary Swan, PhD, RAC, recounts how our A-Team of regulatory experts provided strategic guidance at the pre-FDA meeting to secure alignment on the communication strategy for our client's NDA submission, which was filed shortly after that. Our client received approval for all indications, including pediatric patients, marking a significant milestone in the client’s journey and securing them 10 years of market exclusivity.    READ the Case Study: https://lnkd.in/gnmzCnQ9   #Allucent #BringNewTherapiesToLight #CRO #FDA #DrugDiscovery #RegulatoryStrategy #Storyboarding #ClinicalResearch

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The 2024 jurisdictional Drug Trends reports are now live! You can view key findings from the Illicit Drug Reporting System (IDRS) and the Ecstasy and Related Drugs Reporting System (EDRS) interviews for each state and territory in the latest Drug Trends newsletter here: https://lnkd.in/g3t5-nQX

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PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" and "Aide Memoire on Remote Assessments", defining and describing three types of remote assessments and one combination type: https://lnkd.in/ecmzY29T

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Please see our latest thoughts, including what companies should consider next in relation to the Final Rule on LDTs from FDA. #reedsmith #LDTs #FDA #whatsnext

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The USPTO and the FDA interact in several important ways regarding intellectual property, particularly in the context of pharmaceuticals and medical devices. Here’s an overview of their interaction: 1. Patent Information Submission - When a pharmaceutical or biologic product is submitted for approval to the FDA, the applicant must provide information about any relevant patents associated with the drug or device. - This includes a list of patents that cover the product, its formulation, and its method of use, which the FDA uses to inform its review process. 2. Data Exclusivity - The FDA grants periods of data exclusivity for new drugs and biologics, which can run concurrently with patent protection. This exclusivity prevents other manufacturers from using the clinical data submitted to the FDA for a certain period, thus indirectly supporting the patent system. - The FDA and USPTO both consider the implications of exclusivity when assessing the competitive landscape for a product. 3. Abbreviated New Drug Applications (ANDA) - In the context of ANDA submissions for generic drugs, the FDA requires applicants to certify their stance on any listed patents for the brand-name drug. This includes certifications asserting that the patent is invalid, will not be infringed, or has expired. - The interaction here often leads to legal challenges between brand-name and generic manufacturers regarding patent validity and infringement. 4. Biosimilars and the “Patent Dance” - For biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) outlines a process for resolving patent disputes, commonly referred to as the "patent dance." This process involves the FDA facilitating the exchange of patent information between the biosimilar applicant and the reference product sponsor. - This interaction encourages transparency and can lead to negotiations that help avoid litigation. 5. Regulatory Framework - Both the FDA and USPTO operate under the broader framework of U.S. intellectual property law, ensuring that innovations in pharmaceuticals and medical devices are adequately protected while also encouraging competition and access to medicines. 6. Public Health and Innovation Balance - The FDA focuses on ensuring the safety and efficacy of products, while the USPTO is concerned with protecting inventors’ rights. Their interaction is crucial in maintaining a balance between fostering innovation through IP rights and ensuring public access to safe and effective medicines. Summary In summary, the interaction between the USPTO and the FDA regarding intellectual property is characterized by the submission and review of patent information, data exclusivity provisions, the regulatory processes for generic and biosimilar drugs, and a shared commitment to balancing innovation with public health needs. This collaboration helps to ensure that intellectual property rights do not hinder access to safe and effective medical products.

Katie Blank, regulatory affairs specialist at BD, got her RCC credential because "the reality is that MDR is influencing regulations internationally." "I wanted to make sure that I had a good understanding of the EU regulations so I could see how they're shaping regulations in other countries.” The RCC credentials are RAPS' new certifications that validate your knowledge of European regulations related to IVDs or medical devices. Learn more about the RCC credentials, which are earned by passing an RCC-MDR exam or an RCC-IVDR exam: https://bit.ly/3JM6zTg

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#Generic Drug Company Resolves Price Fixing Claims The woes for generic manufacturers continue. The USAO for the Eastern District of Pennsylvania has announced a resolution with Glenmark Pharmaceuticals involving #FalseClaimsAct, #antitrust, and #antikickback, all related to an price fixing conspiracy. The Drug at Issue: The resolution involved #pravastatin, which is used to treat high #cholesterol and #triglycerides. #FCA: #Glenmark agreed to a—not very impressive—$25 million payment to resolve False Claims Act allegations related to a conspiracy “to fix the price of a generic drug”. The USAO was quick to note that this “collusion” based FCA settlement payment reflected an “ability to pay” reduction. #AKS: The government also alleged that Glenmark “paid and received“ compensation “prohibited by the Anti-Kickback Statute” involving “arrangements on price, supply and allocation of customers” with “other [unnamed] #pharmaceutical manufacturers”. It’s pretty unusual for a defendant in an AKS case to be alleged to have been both on the paying and receiving end of #kickbacks. Lots of Government Programs: The case resolution included #Medicare, #Medicaid, and #Tricare. Deferred #Prosecution: In addition to this FCA settlement, Glenmark had previously entered into a deferred prosecution agreement with the U.S. Department of Justice’s Antitrust Division, which resolved parallel criminal charges. As part of that resolution, Glenmark paid a criminal penalty of $30 million—also based on “its ability to pay”. Although this civil resolution did not involve Glenmark admitting to its wrongdoing, the criminal resolution did. There, Glenmark admitted to “conspiring with two other generic drug companies to fix prices on pravastatin”. A String of Investigations: The #DOJ press release proudly emphasized that this is the “sixth resolution arising from … the … investigation of price fixing by generic drug manufacturers”. It won’t be the last. #lifescienses #healthcare #fraud #healthcarefraud #compliance #healthcarecompliance #generics #genericdrugs

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Join us tomorrow at 1 p.m. CT for a webinar all about drug testing with the Drug Screening Compliance Institute! Register 👉 https://ow.ly/7R8y50UapK0 Key topics: ✅ 2024 legal updates ✅ Evolving drug testing strategies ✅ Latest workplace substance use data ✅ Off-duty lawful products protection trend ✅ Marijuana impairment: legal & practical perspective *This webinar is approved for 1 hour of SHRM and HRCI credit. P.S. Can't make it? Register anyway and we'll send you a link to the recording and the slides afterward! #drugtesting #backgroundchecks

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New guidance from the #FDA outlines a path to obtain preapproval for minor changes to #AI-enabled #medicaldevices after they're on the market, potentially boosting research and development by easing the regulatory burden on manufacturers. #Publicpolicy attorney John T. Vaughan, however, cautioned the agency could still face a hefty workload to stay on top of a quickly advancing field. Read his remarks to Bloomberg Law to learn more. https://bit.ly/4j4qIEg #artificialintelligence #lifesciences

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💊 ⚕ I met a 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗱𝗶𝗿𝗲𝗰𝘁𝗼𝗿 who was struggling to keep her team up to date with ever-changing regulatory standards. 😟📋 The complexities of new regulations left his team feeling overwhelmed and underprepared, risking non-compliance during critical audits. 🚨 🏥 𝗛𝗲𝗿𝗲’𝘀 𝗵𝗼𝘄 𝘄𝗲’𝗿𝗲 𝗮𝗱𝗱𝗿𝗲𝘀𝘀𝗶𝗻𝗴 𝘁𝗵𝗶𝘀 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲: we designed a tailored training framework that aligns with the latest compliance requirements and offers frequent updates. 🎯✅ We set up monthly workshops and on-demand learning modules to cover emerging regulatory changes. 📅📚 Consistent training empowers teams to quickly adapt to new regulations and apply best practices. 💪📈 We systematically requested feedback to verify the improvements achieved. 📝🔍 This approach 𝗶𝗺𝗽𝗿𝗼𝘃𝗲𝗱 the team’s audit performance when being audited, reducing major observations by 𝟲𝟱% and demonstrating reduced compliance risks. 📉🔒 If you want to enhance your training strategy and maintain compliance, 𝗗𝗠 𝗺𝗲 the word '𝗧𝗥𝗔𝗜𝗡𝗜𝗡𝗚' and your email address and I'll send you a 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗰𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁 𝗳𝗼𝗿 𝗳𝗿𝗲𝗲. 📨📑 #pharmaceuticalindustry #pharmaceuticals #pharmaceuticaltraining

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This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions. https://lnkd.in/dxdcrJ-e

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Why do different IRBs have different noncompliance reporting policies? Find out in our recently updated blog:

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Periodic Safety Update Reports (PSURs) are essential for monitoring the safety and efficacy of medications post-approval. They analyze real-world data to uncover rare adverse reactions and ensure ongoing public health protection. Discover how PSURs evolved into Periodic Benefit-Risk Evaluation Reports (PBRERs) and their crucial role in safeguarding our health. Read more from Clinical Leader!

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