where experts go to learn about the FDA
FDA Law Blog
where experts go to learn about FDA
Menu
Menu
Practices
Industries
FDA Regulatory Categories
Professionals
About Us
Contact
LinkedIn
Twitter
FDA Law Blog
News & Events
LinkedIn
Twitter
Recent Posts
Days Go By* – Particularly When Responding to an FDA Inspection
September 13, 2024
Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
September 12, 2024
Sixteen HP&M Attorneys Recognized by Best Lawyers® in 2025 in America
September 5, 2024
Where Have All the De Novo Summaries Gone: An Update
September 4, 2024
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
September 3, 2024
Trackers
180-Day Exclusivity Tracker
FDA Citizen Petition Tracker
REMS Tracker (Historical – Not Recently Updated)
FDA Legislation Tracker
Orange Book Archives
Scorecards
Generic Drug Labeling Carve-Out Scorecard
Biosimilars State Legislation Scorecard (Historical – Not Recently Updated)
Blogroll
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
Resources
Centers for Medicare & Medicaid Services
Drug Enforcement Administration
Food and Drug Administration
Categories
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
OPDP12-18-1
December 19, 2023
By
Kurt R. Karst
—
Search FDA Law Blog
Subscribe
Never miss a post from FDA Law Blog
Name:
Your email address:
*
Leave this field empty if you're human:
Latest Tweets
Tweets by @fdalawblog
Awards & Honors
The Best
Lawyers in America
US News & World Report
Ranked in Chambers USA 2018
Recent Posts
Days Go By* – Particularly When Responding to an FDA Inspection
September 13, 2024
Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
September 12, 2024
Sixteen HP&M Attorneys Recognized by Best Lawyers® in 2025 in America
September 5, 2024
Where Have All the De Novo Summaries Gone: An Update
September 4, 2024
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
September 3, 2024
Trackers
180-Day Exclusivity Tracker
FDA Citizen Petition Tracker
REMS Tracker (Historical – Not Recently Updated)
FDA Legislation Tracker
Orange Book Archives
Scorecards
Generic Drug Labeling Carve-Out Scorecard
Biosimilars State Legislation Scorecard (Historical – Not Recently Updated)
Blogroll
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
Resources
Centers for Medicare & Medicaid Services
Drug Enforcement Administration
Food and Drug Administration
Categories
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