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This Just In: NIH Extends the Comment Period for its Proposed Rule on Clinical Trials Registration and Results Reporting
February 15, 2015By James E. Valentine* & Anne Marie Murphy –
The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to expand and clarify many of FDAAA’s requirements for submitting registration and summary results information for specified clinical trials of drugs, biologics, and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov.
This month-long extension will provide current and future “responsible parties” of “applicable clinical trials,” as well as other stakeholders, additional time to weigh in on NIH’s proposed changes (e.g., requiring results for trials of products that are not approved), as well as areas where the Agency has requested specific feedback (e.g., whether to require lay and/or technical results summaries). For a synopsis of the changes proposed in the NPRM, see our previous posts here and here. Comments can be submitted to docket number NIH-2011-0003 at Regulations.gov.
*Admitted only in Maryland. Work supervised by the Firm while D.C. application pending.
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- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 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