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Article Examines Trends in FDA’s Use of Class-Wide REMS
December 27, 2009By William T. Koustas –
As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is increasing. (See our REMS Tracker.) The most notable example of this is the class-wide REMS for extended-release opioid drugs, where FDA may impose onerous new requirements on the manufacturers, prescribers, dispensers and consumers of such products. In light of these developments, a recent article in the December issue of the Regulatory Affairs Professionals Society’s Regulatory Focus publication authored by Hyman, Phelps & McNamara’s William T. Koustas, titled “Trends in FDA’s Use of Class-wide REMS,” explores the current state of class-wide REMS through interesting and relevant examples. Understanding FDA’s current implementation of class-wide REMS may be the best means of preparing for the future use of REMS.
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- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2 March 17, 2023
- FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations March 16, 2023
- Ricardo Carvajal to Moderate Panel at FDLI’s Food and Dietary Supplement Safety and Regulation Conference March 16, 2023
- 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