- So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups February 7, 2023
- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
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Must FDA Treat Similarly-Situated Competitors the Same Way?
December 29, 2010In his latest article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Director John R. Fleder explores whether the FDA should enforce the FDC Act by giving different treatment to similarly-situated competitors. The article reaches the conclusion that the public is not well served if companies correctly conclude that they are being held to a harsher standard than their competitors. Mr. Fleder explains why the best way to avoid this concern is for FDA to take a nationwide approach to enforcement decisions. He argues that an FDA decision to take an enforcement action must be preceded by an analysis by the agency of whether it is unfairly singling out one competitor for an enforcement action while leaving competitors free from the public stigma of an FDA enforcement action.
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- So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups February 7, 2023
- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- 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