- FDA Guidance Sheds (Some) New Light on 3-Year New Clinical Investigation Exclusivity March 5, 2026
- Federal Court Preliminarily Enjoins Texas Labeling Law February 27, 2026
- Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” and “Usual Course of Professional Practice” Regulations February 26, 2026
- The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding February 23, 2026
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FDA Fiddles With Remote Drug Inspections While Pharma Burns
December 10, 2020For over nine months FDA has dithered on whether and, if so how, to conduct remote inspections of drug facilities during the pandemic. On the other hand, many foreign regulatory bodies appear to have implemented just such a system of remote inspections. Has FDA just decided to wait out the pandemic? Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz discussed this issue and more in an op-ed published earlier this week with Bloomberg News.
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- FDA Guidance Sheds (Some) New Light on 3-Year New Clinical Investigation Exclusivity March 5, 2026
- Federal Court Preliminarily Enjoins Texas Labeling Law February 27, 2026
- Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” and “Usual Course of Professional Practice” Regulations February 26, 2026
- The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding February 23, 2026
- Rare Disease Month Developments – Part 3: The Ugly (just kidding) – See You at Rare Disease Week February 20, 2026
- 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