- Rare Disease Month Developments, Part 2 –The Bad: Proposed Closing of an Orphan User Fee “Loophole” & Renewed Concerns Regarding FDA Consistency February 18, 2026
- Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda & Plausible Mechanism Draft Guidance On Its Way February 17, 2026
- Who Qualifies for the New FDA PreCheck Pilot Program? February 16, 2026
- Understanding FDA’s Risk-Based Inspection Model Under QMSR February 13, 2026
- Can a Citizen Petition Denial Turn a Warning Letter Into Final Agency Action? The Curious Case of Hybrid Pharma February 12, 2026
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FDA’s Chief Counsel, Ralph Tyler, Set to Leave FDA
June 30, 2011About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg. Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of the State of Maryland (see our previous post here). Mr. Tyler's last day at FDA will be August 5, 2011. We understand that an Acting FDA Chief Counsel has not yet been named.
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- Rare Disease Month Developments, Part 2 –The Bad: Proposed Closing of an Orphan User Fee “Loophole” & Renewed Concerns Regarding FDA Consistency February 18, 2026
- Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda & Plausible Mechanism Draft Guidance On Its Way February 17, 2026
- Who Qualifies for the New FDA PreCheck Pilot Program? February 16, 2026
- Understanding FDA’s Risk-Based Inspection Model Under QMSR February 13, 2026
- Can a Citizen Petition Denial Turn a Warning Letter Into Final Agency Action? The Curious Case of Hybrid Pharma February 12, 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