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- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors March 20, 2024
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HP&M Attorneys Author Chapters in FDLI’s “Bringing Your Pharmaceutical Drug to Market” Guidebook
April 28, 2015In a new guidebook published by the Food and Drug Law Institute, David B. Clissold and James E. Valentine of Hyman, Phelps & McNamara, P.C. co-authored Chapter 3-1, “FDA Regulatory Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.”
Both chapters cover essential elements of development and approval of pharmaceutical products in the United States. The “FDA Regulatory Scheme” chapter provides a thorough overview of FDA’s laws, regulations, and guidance on drug development, including regulatory approval pathways, preclinical and clinical development, expedited development, and postmarket requirements. The “Orphan Drugs” chapter discusses FDA’s orphan drugs program, including the process for requesting orphan drug designation, the benefits associated with designation, and orphan drug exclusivity. The chapter also discusses key aspects of drug development for rare diseases, including FDA’s tropical disease and rare pediatric disease voucher programs, clinical trial design for rare diseases, patient advocacy, special considerations for developing drugs for rare pediatric diseases, and FDA’s historic flexibility in orphan drug approval.
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- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors March 20, 2024
- 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