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On June 4, 2018, FDA posted a statement from CDER Director Janet Woodcock announcing a multi-pronged FDA initiative to modernize FDA’s drug review offices and processes. The initiative will involve:
- Staffing increases
- Increasing the number of review offices from the current 5 to 9 and the review divisions from the current 19 to 30
- Establishing a multi-disciplinary review team at the outset of an application review, replacing the current system where the review division consults with other FDA offices as necessary during the course of a review
- Centralizing review procedures so that they are consistent across all review divisions, rather than having division-specific procedures, and concentrating administrative management within a group of regulatory experts
- Establishing a unified post-market safety surveillance system to monitor safety both pre- and post-approval
- Enhancing the patient’s voice in drug development
Click here for Dr. Woodcock’s statement, and here for a related statement from FDA Commissioner Gottlieb. Although this appears to be a significant internal initiative and reorganization, both statements contain very limited detail. There is only preliminary information on what the 30 review divisions will be, as captured in the illustration below from BioCentury. We’ll be monitoring this initiative and posting more information as we receive it.
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- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- 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