FDA Regulatory

Greg Levine and Ed McNicholas Recognized as 2020 Washington D.C. Trailblazers by The National Law Journal (September 2, 2020)
Life Sciences Compliance Attorneys Examine CARES Act OTC Drug Framework Overhaul (June 2, 2020)
In MedTech Dive, Kellie Combs Examines FDA Guidance on Digital Health Devices for Treating Psychiatric Disorders (April 28, 2020)
FDA Regulatory Chair Presents at Food and Drug Law Institute’s Webinar on FDA’s Recent COVID-19 Guidances (April 17, 2020)
In Law360, FDA Regulatory Attorneys Examine How COVID-19 May Spur Passage of Lab Test Reform Legislation (April 8, 2020)
Greg Levine Navigates Coronavirus Lab Test Developer Through Novel FDA Process (March 18, 2020)
In Law360, Washington Attorneys Examine FDA & FTC Biosimilar Initiatives (February 20, 2020)
Life Sciences Regulatory & Compliance Practice Chair Profiled in Law360 FDA Focus Column (January 22, 2020)
In Law360, Attorneys Examine When DOJ Seeks Dismissals of Life Sciences False Claims Act Cases (December 16, 2019)
In Bloomberg Law, Health Care Attorney Addresses Delay in Harmonizing Human Research Rules (December 16, 2019)
Valerie Bonham Appointed to National Academy of Sciences’ Board on Life Sciences (December 10, 2019)
In Law360, Washington Attorneys Examine U.S. Supreme Court Kisor Case for Challenges to FDA Actions (December 4, 2019)
Ropes & Gray Attorneys to Moderate Webinar on Self-Disclosure for Grant Recipients (October 4, 2019)
In MedTech Dive, Greg Levine Addresses FDA Guidance on Regulating Clinical Decision Support Software (October 2, 2019)
In Bloomberg Law, Valerie Bonham Examines Foreign Influence in Federally-Funded Research (October 1, 2019)
Life Sciences Attorneys Present at Food and Drug Law Institute Biologicals Law Course (September 27, 2019)
Life Sciences and Intellectual Property Practices Honored With Two LMG 2019 Life Sciences Awards (September 23, 2019)
In Law360, Life Sciences Regulatory & Compliance Attorneys Address Drug Compounding Risks at Outsourcing Facilities (September 23, 2019)
Valerie H. Bonham, NIH Veteran and Leader in Biomedical Research Compliance and Bioethics, Joins Ropes & Gray as Health Care Counsel (June 25, 2019)
In Law360, Washington, D.C. Attorneys Examine Guidance on False Claims Act Cooperation Credit for Life Sciences Companies (June 19, 2019)
In Law360, Life Sciences Attorneys Examine FDA Voluntary Recall Draft Guidance (May 30, 2019)
In Bloomberg Law, Health Care Partner Examines Final Rule on Drugmaker TV Ad Price Disclosures (May 14, 2019)
In Law360, Life Sciences Attorneys Examine FDA Draft Guidance on Medical Device Inspections (May 13, 2019)
In Pink Sheet, Life Sciences Partner Discusses Drug Pre-Approval Promotion (March 28, 2019)
Outlook 2019 Teleconference: Washington, D.C. Updates and Insights on Life Sciences and Health Care (January 23, 2018)
Cross-Practice Team Authors Law360 Article on FDA’s Right to Try Act and Expanded Access Pathway (December 18, 2018)
FDA Regulatory Attorney Discusses Enforcement Priorities & Whistleblower Lawsuits in Medtech Insight (November 15, 2018)
Ropes & Gray Adds Experienced FDA Counsel in Washington, D.C. (October 22, 2018)
Health Care Partner Addresses FDA Bid to Lower Drug Prices in The Washington Post (July 19, 2018)
In Law360, Attorneys Examine FDA Final Guidance on Payor Communications and Communications Consistent with Labeling (June 27, 2018)
In Inside Health Policy and Medical Marketing & Media, Life Sciences Partner Addresses FDA Final Guidance on Payor Communications and Communications Consistent with the Labeling (June 15, 2018)
In Medical Marketing & Media, Life Sciences Partner Addresses Healthcare Marketing Changes Under Trump Administration (May 29, 2018)
In Bloomberg Law, Life Sciences Co-Chair Addresses FDA Medical Device Clearance Proposal (April 17, 2018)
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications (April 12, 2018)
Event - Outlook 2018 Teleconference: The Trump Administration’s Impact on Life Sciences and Health Care—the First Year
The Latest FDA Move To Limit Digital Health Software Regs (December 22, 2017)
FDA Issues Draft Guidances to Scale Back Regulation of Digital Health Software (December 13, 2017)
In Law360, Life Sciences and Corporate Team Examines FDA Move to Limit Digital Software Regulations (December 22, 2017)
FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications (January 31, 2017)
Event - Outlook 2017: The New Administration and Its Impact on Life Sciences and Health Care (January 25, 2017)
Health Care and FDA Changes Expected Under Trump Administration (January 11, 2017)
“The New FDA: Product Development, Pricing and Beyond,” JD Supra Business Advisor (January 6, 2017)
“The New U.S. Department of Health and Human Services: Tom Price and Value-Based Health Care,” JD Supra Business Advisor (January 6, 2017)
“Life Sciences Legislation and Regulation to Watch In 2017,” Law360 (January 2, 2017)
Podcast - The New FDA: Product Development, Pricing and Beyond (December 22, 2016)
21st Century Cures Act – Provisions Relating to Development Incentives for Certain Classes of Drugs (December 13, 2016)
21st Century Cures Act – Provisions Relating to Digital Health (December 13, 2016)
21st Century Cures Act – Provisions Relating to Reimbursement & Fraud and Abuse (December 13, 2016)
21st Century Cures Act – Provisions to Promote Drug Development (December 13, 2016)
21st Century Cures Act – Provisions Relating to Medical Device Innovation (December 13, 2016)
21st Century Cures Act – Provisions Relating to Regulation of Clinical Research (December 13, 2016)
Podcast - FDA Holds Public Hearing on Manufacturer Communication of Scientific and Medical Information (November 14, 2016)

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