- The RFD Process: Time for Reform? June 30, 2025
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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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- The RFD Process: Time for Reform? June 30, 2025
- New Report on Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry June 26, 2025
- FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price June 26, 2025
- Last Friday was a Good Day for Those Who Want to Litigate Against the Federal Government June 23, 2025
- FDA’s New Priority Voucher Pilot Program Has Landed: CNPV June 19, 2025
- 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