- FDA Cracks Down on ClinicalTrials.gov Reporting Failures May 4, 2021
- I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1) May 3, 2021
- The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”) April 30, 2021
- FASTER Law Adds Sesame as Major Food Allergen April 27, 2021
- The Fifth Circuit Addresses Pay-for-Delay Agreements: Money for Nothing (and Patent Settlements for Free?) April 26, 2021
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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 Cracks Down on ClinicalTrials.gov Reporting Failures May 4, 2021
- I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1) May 3, 2021
- The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”) April 30, 2021
- FASTER Law Adds Sesame as Major Food Allergen April 27, 2021
- The Fifth Circuit Addresses Pay-for-Delay Agreements: Money for Nothing (and Patent Settlements for Free?) April 26, 2021
- 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