Joshua Oyster

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Josh Oyster steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Among the many clients Josh counsels are leading life sciences and health care companies, as well as private equity firms and investment banks focused on investing in these sectors.

With a deep command of the subject matter—and a talent for translating complex regulations into practical, strategic advice—Josh is regularly called upon for help with a range of enforcement, regulatory compliance and transactional matters. Josh routinely helps companies navigate FDA inspections, Warning Letters, product recalls, and other compliance and enforcement matters. He is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, drug compounding, data integrity, CBD, and developments arising from the COVID-19 pandemic. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments in FDA-regulated entities.

What clients appreciate most about Josh is his ability to see the big picture, as he seeks to understand not only the legal issues but also a company’s business and products. With prior in-house and secondment experience at leading health care and life sciences companies, Josh can readily connect with clients’ internal teams to offer tailored and timely advice to both lawyers and non-lawyers alike.

Josh frequently writes about FDA-related “hot topics” and presents at industry conferences.

Experience

Enforcement and Investigations

Counseled a global medical device manufacturer regarding responses to FDA inspections, field actions, and internal initiatives relating to regulatory compliance and quality.
Advised a specialty pharmaceutical manufacturer regarding compliance with FDA data integrity requirements and responding to FDA inspections and Warning Letters.
Counseled a pharmaceutical company regarding its compliance obligations under an FDA consent decree.
Counseled a leading device manufacturer and drafted responses to FDA in relation to a field action for an orthopedics device.
Conducted an internal investigation of in vitro diagnostics manufacturer related to alleged noncompliance with FDA and CLIA requirements.
Advised in vitro diagnostics manufacturer regarding its response to an FDA Form 483 inspection report related to violations of the quality system regulation.
Advised multiple medical device manufacturers defending government investigations into their compliance with the quality system regulation and reporting of corrections and removals under 21 C.F.R. Part 806.

Regulatory Compliance and Counseling

Regularly advises drug manufacturers on the latest policy developments and enforcement trends relating to advertising and promotion.
Regularly advises medical device and technology firms regarding FDA’s digital health policies, including the regulation of mobile medical applications and clinical decision support tools.
Evaluated the overall effectiveness of the FDA and health care compliance program of a global pharmaceutical firm.
Updated global pharmaceutical firm’s policies related to communication of scientific and medical information in light of evolving policy and enforcement landscape.
Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
Supported drug manufacturer with its request to FDA to modify certain post-marketing studies required under the Pediatric Research Equity Act.
Counseled a drug manufacturer on the FDA approval pathways for new indications for the manufacturer’s drug, as well as regulatory issues under the Hatch-Waxman Act.
Regularly conducts reviews of medical device and pharmaceutical manufacturers’ advertising and promotional materials.
Represented a sterile compounding pharmacy on compliance matters associated with FDA and state regulatory issues, including inspection responses, regulatory correspondence, and new legislation.

Transactional Support

Regularly performs FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies and other acquisitions and investments in FDA-regulated firms on behalf of both private equity firms and strategic buyers.
Advised private equity firms on multiple transactions involving compounding pharmacies and provided advice regarding the impact of the federal Drug Quality and Security Act.
Performed FDA regulatory diligence for a private equity firm investing in health and beauty company marketing CBD-containing cosmetics.
Conducted regulatory due diligence of multiple firms marketing herbal supplements, beauty-focused supplements, and similar products on behalf of private equity client.
Performed health care regulatory diligence for private equity firm’s acquisition of a clinical laboratory and assessed compliance risks related to fraud and abuse laws, and CLIA.

Credentials

Education

JD, with highest honors, The George Washington University Law School, 2012; Order of the Coif; associate, The George Washington University Law Review; member, Moot Court Board; member, Mock Trial Board; member, Alternative Dispute Resolution Board
BS (Biological Anthropology & Anatomy), magna cum laude; with distinction, Duke University, 2008; Phi Beta Kappa

Admissions

District of Columbia, 2013
California, 2012
Kentucky, 2018
U.S. Court of Appeals for Veterans Claims, 2013

Publications

Co-author, “‘Modernized’ Food Manufacturing Enforcement: Trends in FDA Warning Letters,” Food and Drug Law Institute Update Magazine (March 8, 2024)
Co-author, “Top 10 Takeaways From FDA’s Revised Quality System Requirements for Medical Devices,” Westlaw Today (February 26, 2024)
Co-author, “First Circuit Affirms Convictions of Former Acclarent Executives Related to Off-Label Promotion of Medical Device,” Westlaw Today (January 3, 2024)
Quoted, “FDA Prepares for High Court, Final Rule Moves in Election Year,” Bloomberg Law (December 28, 2023)
Co-author, “Reading The Fine Print on FDA’s Prescription Drug Ad Rule,” Law360 (December 8, 2023)
Co-author, “Try, Try Again: FDA Issues Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products,” Westlaw Today (November 7, 2023)
Quoted, “Year-End FDA Decisions May Bring New 503B Compounding Regs for 2024,” Pharmacy Practice News (November 7, 2023)
Quoted, “Weight-Loss Drugmakers in ‘Whack-a-Mole’ Fight Against Knockoffs,” Bloomberg Law (November 1, 2023)
Co-author, “FDA Publishes Draft Guidance on Prescription Drug Use-Related Software,” Westlaw Today (October 6, 2023)
Co-author, “A Step Forward: FDA Issues 3 Draft Guidance Documents as Part of Efforts to Modernize the 510(k) Notification Pathway,” Westlaw Today (September 28, 2023)
Quoted, “Abortion Drug Access Limits Unclear as Fight Goes to High Court,” Bloomberg Law (August 18, 2023)
Co-author, “U.S Medical Device Recalls Resource Manual,” Ropes & Gray (July 17, 2023)
Co-author, “Preparing for FDA’s Surprise Foreign Drug Inspection Regime” Law360 (June 28, 2023)
Co-author, “Beyond Mifepristone: The potential implications of AHM v. FDA on FDA's authority,” Daily Journal (April 13, 2023)
Quoted, “Using Social Media for Product Promotions,” FDA News (January 4, 2023)
Co-author, “Potential Upheaval For FDA Regulation of Stem Cell Clinics,” Law360 (January 3, 2023)
Co-author, “FDA’s Proposed Medical Device Rule is Promising, But Hasty,” Law360 (March 23, 2022)
Co-author, “Drug CGMP During COVID-19: An Analysis of Recent FDA Warning Letters,” Food and Drug Law Institute Update (Spring 2022)
Co-author, “Expect Aggressive Life Sciences Enforcement In 2022,” Law360 (February 14, 2022)
Co-author, “2021 Enforcement Review: FDA-Regulated Medical Products,” Ropes & Gray Article (January 31, 2022)
Co-author, “What’s Next for COVID-Era Emergency Use Medical Devices,” Law360 (January 19, 2022)
Co-author, “High Court's AMG Ruling Could Hinder FDA Enforcement,” Law360 (May 5, 2021)
Co-author, “Review of 2020 FDA Enforcement Activities,” Policy & Medicine (February 15, 2021)
Co-author, “Deconstructing the Consent Decree: A Primer and Recent Trends for FDCA Injunctions,” Food & Drug Law Institute Update Magazine (Winter 2020)
Co-author, “HHS Opinions Signal Broad Immunity From COVID-19 Liability,” Law360 (November 6, 2020)
Co-author, “Questions Raised By FDA's New Lab Test Policy,” Law360 (October 20, 2020)
Co-author, “Keeping Track of the Quacks: Drug and Device Enforcement in the COVID-19 Era,” Food and Drug Law Institute Update Magazine (Fall 2020)
Co-author, “HHS Lab Test Rule's Likely Impact During And After COVID-19,” Law360 (August 31, 2020)
Co-author, “When DOJ Seeks Dismissals Of Life Sciences FCA Cases,” Law360 (December 12, 2019)
Co-authored, “Outsourcing Facilities Face Rising Drug Compounding Risks,” Law360 (September 18, 2019)
Co-author, “How FDA is Refreshing its Recall Readiness Guidance,” Law360 (May 29, 2019)
Co-author, “What Fed. Circ. False Ad Ruling Means For Section 337 Claims,” Law360 (May 14, 2019)
Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)
Quoted, “FDA Ad and Promo Enforcement Targets Presentation of Risk Info, Pre-Approval Promotions,” Drug Industry Daily (May 1, 2018)
Co-author, “Back to first principles: a new model for the regulation of drug promotion,” Journal of Law and the Biosciences (April 2015)
Co-author, “POM V. Coke May Impact Many FDA-Regulated Products,” Law360 (May 8, 2014)
Co-author, “Preclusion, Primary Jurisdiction, and Private Enforcement: The Intersection of the Lanham Act and the Federal Food, Drug, and Cosmetic Act,” Bloomberg BNA’s Pharmaceutical Law and Industry Report (April 18, 2014)

Presentations

Speaker, “Expectations for the Final Rule on Laboratory Developed Tests: Focus on Software Interaction,” Current Developments in Digital Health Technology and Regulation Conference (February 1, 2024)
Speaker, “FDA in 2024: What to Expect in an Election Year,” FDANews (October 26, 2023)
Presenter, “Modernizing Food and Drug Administration Recalls Listening Session,” U.S. Food and Drug Administration (September 29, 2023)
Speaker, “Significant FDA Enforcement Developments: Challenges and Opportunities,” The Knowledge Group Webcast (May 24, 2023)
Speaker, “Due Diligence: Ensuring Regulatory Control and Compliance Post-Acquisition,” 2023 Food and Drug Law Institute Annual Conference (May 17, 2023)
Speaker, “Impact of Mifepristone Legal Challenges in Massachusetts,” Boston Bar Association Webinar (May 4, 2023)
Speaker, “Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations,” ACI FDA Boot Camp (March 21, 2023)
Presenter, “Considerations for Company Mergers and Acquisitions,” Drug Information Association’s Advertising and Promotion Regulatory Affairs Conference (February 23, 2023)
Presenter, “FDA’s Recent Medical Device Recalls and Enforcement, Use of Section 518 Authority, and How to Best Prepare,” Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference Washington, D.C. (December 7, 2022)
Presenter, “Inside the FDA,” Specialty Pharmacy Law Conference, National Association of Specialty Pharmacy’s Annual Meeting (September 12, 2022)
Presenter, “Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules” FDAnews Webinar (April 28, 2022)
Presenter, “Public Readiness and Emergency Preparedness Act,” Food and Drug Law Institute’s COVID-19: Introduction to FDA’s Legal Authorities and Emerging Issues (August 18, 2020)
Presenter, “Violations, Enforcement and International Issues,” Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation (April 1, 2020)
Presenter, “FDA Promotional Considerations for Pharmacometric Tools,” American Conference on Pharmcometrics Pre-Conference, Orlando, F.L. (October 20, 2019)
Presenter, “Violations, Enforcement and International Issues” Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation, Washington, D.C. (October 2, 2019)
Panelist, “Precision Dosing: A Focus on Solutions,” FDA Workshop: Precision Dosing: Defining the Need and Approach to Deliver Individualized Drug Dosing in the Real World Setting, Silver Spring, M.D. (August 12, 2019)
Speaker, “Regulation of Drug Manufacturing,” Food and Drug Law Institute Introduction to Drug Law and Regulation, Washington, D.C. (November 8, 2018)
Speaker, “Advertising & Promotion: Compliance Tips from Recent Warning and Untitled Letters,” FDANews Webinar (April 26, 2018)

Experience

Credentials

Education

Admissions

Publications

Presentations

Awards

Professional & Civic Activities

Areas of Practice