- RRA, RIE and MRA: FDA’s Evolving Inspection Toolkit Still Has Boundaries October 8, 2025
- Inside Warning Letters: A Statistical Update October 7, 2025
- Carve Away: D.C. Circuit Keeping the “Chubby Label” Carve-Out Alive October 6, 2025
- Request for Comments: AI-Enabled Medical Devices October 3, 2025
- The U.S. House Introduces Bill to Expand Compounding During Drug Shortages, Provide Clarity on Bulk Substance “USP/NF Monograph” Definition, and Get Rid of Section 503A’s Tortured MOU Provision October 2, 2025
- Big Molecule Watch Blog
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- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
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HP&M Releases 2018 Litigation Briefing
January 9, 2019Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We also include at the end of the report the hot-button cases we are monitoring in 2019 that may shape future FDA regulation.
We hope this report proves useful and interesting to you. For more information about HP&M, please go to our website at www.hpm.com.
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- RRA, RIE and MRA: FDA’s Evolving Inspection Toolkit Still Has Boundaries October 8, 2025
- Inside Warning Letters: A Statistical Update October 7, 2025
- Carve Away: D.C. Circuit Keeping the “Chubby Label” Carve-Out Alive October 6, 2025
- Request for Comments: AI-Enabled Medical Devices October 3, 2025
- The U.S. House Introduces Bill to Expand Compounding During Drug Shortages, Provide Clarity on Bulk Substance “USP/NF Monograph” Definition, and Get Rid of Section 503A’s Tortured MOU Provision October 2, 2025
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized