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Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. So, yes, compliance and quality still matter, a lot. By John W.M. How will the cuts at FDA impact inspections and enforcement?
Case Study 2: Novel Formulation of Existing Drug A biotech firm discovered a branded drug with a novel formulation that significantly improved patient compliance. Biosimilars and Complex Generics The rise of biosimilars and complex generics is changing the dynamics of market exclusivity.
By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations.
Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.
Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.
Specifically, manufacturing/testing procedures and compliance with cGMPs. Conducting internal investigations and audits of manufacturing facilities for compliance with 21 CFR 211/600. Preparing for and responding to government inspections and other compliance matters.
By investing in streamlined systems that create a single version of truth for aggregating, managing and analysing data, biotech firms can ensure compliance with regulatory requirements, increase efficiency, and potentially reduce overall clinical development time.
The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Most of FDAs reviewers are exempt, while compliance, policy, and administrative support are typically furloughed. What does it mean for FDA staff?
From providing KOL (Key Opinion Leader) engagement personnel to facilitating local regulatory compliance, CSOs serve as essential partners in ensuring the commercial success of pharmaceutical assets across varied healthcare environments. Equally important is regulatory compliance.
By John W.M. Claud & Mark I. Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services.
The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And it is exactly that!
The classification letters are important because they include the special controls with which all similar devices must demonstrate compliance in a future 510(k) submission. The impact of having no de novo classification letters and a lag in posting 510(k) summaries is significant, and will become more significant over time.
Citing the May 6 compliance date for Stage 1 of the LDT Rule, both ACLA and AMP asked that Judge Jordan issue his ruling expeditiously. Judge Jordan said he would issue a decision as soon as possible. Notably, the last question Judge Jordan asked of ACLA was on this specific point. ACLA, of course, confirmed that was true.
Andrew Hull brings his expertise to the firms enforcement, compliance, and litigation practice. She also has extensive experience in advisory committee preparation, authored numerous Guidances for Industry, and co-developed the current drug review process and template. Director Karla L. Palmer, commented.
FDA Law Blog readers are offered a discount of 10% off the registration price. The discount code is 25HYMAN10. You can access conference information and register for the event here.
Recent employee diversion of significant controlled substance quantities from hospitals has resulted in large civil monetary settlements, some in the millions of dollars, and costly compliance remediation programs to resolve allegations.
The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.
The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.
On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY.
Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M.
How can I ensure compliance with ERISA requirements? What can be learned from the economic landscape of biosimilars and specialty therapeutics? What is the best way to design and optimize benefits for covering GLP-1s? What are the latest developments in copay maximizer and accumulator programs? And much more !
The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M.
Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.
It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.
New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.
have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. is an attempt on international collaboration of biosimilar medicines. and Alvotech & CCHT Biopharmaceutical Co.,
President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.
In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months.
Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.
Two Dedicated Tracks for Your Focus Area : This Summit includes tailored content on specialty network design and patient services to customize the learning experience as well as shared content to maximize collaboration and knowledge-sharing View the detailed online agenda and register today.
This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.
We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Teva Pharmaceutical Industries Ltd. NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century.
Pharmacies and distributors should be aware of the noncompliant activity alleged in these cases and tailor their own compliance programs to include at least some of the requirements imposed by the courts. This post examines the Zarzamora pharmacy and prescribing red flags decision. Consent Agreement and Final Judgment ¶ 10.a.-n.
For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.
Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex landscape of advertising and promotion compliance on a global scale. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms.
Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. The seamless use of Data Standards also require compliance with Data Integrity Standards.
We won’t repeat ourselves, but we will summarize—regulatory due diligence and an understanding of historical regulatory compliance issues is a critical component of assessing whether a deal is what it seems to be. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.
Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance. By John W.M.
Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development. Prior to Compliance Architects, Jeff held senior leadership positions as Conference Director and Director of Sales for industry leading provider FDAnews.
This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the corporate compliance chart. Operate legitimate, bona fide, and well-resourced compliance programs. Inspire a culture of compliance. Prevent corporate wrongdoing before it happens. Classics, all.
On the postmarket side, she advises clients on regulatory compliance matters, including complaint handling, MDRs, field actions, promotional review, and QSR compliance. Jennifer also helps clients with contract matters, regulatory due diligence, and public filings. She also specializes in medical device software and digital health.
These fees are critical for funding FDA’s ability to review monographs, inspect facilities, and enforce compliance. Arrears List 2025: A Red Flag for Industry Compliance In June 2025, FDA’s Division of User Fee Management published a 70-page OMUFA Facility Arrears List covering fiscal years 2021 through 2025.
The first day is dedicated to manufacturers, while Days 2 and 3 are for regulatory compliance personnel and mid-level to senior managers. DEA will offer virtual accessibility to those who cannot attend in person. Relevant information and links follow. Click here to VIEW AGENDA.
Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.
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