- Nothing to See Here: FDA Issues Interchangeable Biosimilars Strategy Document September 25, 2026
- T Time: Women Were First to Put Testosterone Back on FDA’s Agenda. Now It’s Industry’s Turn September 23, 2026
- Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure September 15, 2026
- Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory Evidence September 14, 2026
- FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 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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- Nothing to See Here: FDA Issues Interchangeable Biosimilars Strategy Document September 25, 2026
- T Time: Women Were First to Put Testosterone Back on FDA’s Agenda. Now It’s Industry’s Turn September 23, 2026
- Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure September 15, 2026
- Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory Evidence September 14, 2026
- FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 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