- Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024
- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
- Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana April 30, 2024
- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
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Long Awaited Medicaid Rebate Rule Under Review by OMB
August 5, 2015By Alan M. Kirschenbaum –
Yesterday, CMS’s final Medicaid Drug Rebate Program rule arrived on the doorstep of OMB’s Office of Information and Regulatory Affairs (OIRA) for review under Executive Order 12866. Under the Executive Order, OIRA ordinarily has 90 days to complete its review, with the possibility of one 30-day extension with the written approval of the Director of OMB. Of course, OIRA may complete its review sooner. The current Unified Agenda of Regulatory and Deregulatory Actions still identifies August 2015 as the expected time of publication, as it has since May. Note that the expected “final action” date published in the regulatory agenda has been missed multiple times since CMS published the proposed rule in February 2012. However, we can now be relatively confident that the final rule will be published within the next several months. We will be watching for it and will keep our readers posted.
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- Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024
- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
- Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana April 30, 2024
- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 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