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Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay
September 5, 2016Over the course of roughly the last year, gene editing has gone from being a topic limited to scientific conferences to being featured in the New York Times and on the cover of TIME magazine. Most of the attention has been due to a molecular tool with an opaque name but simple acronym: clustered, regularly interspaced, short palindromic repeat (CRISPR) technology. Despite all the attention that has come to CRISPR and gene editing in general, many legal questions linger; it is not immediately clear how the FDA and USDA will approach the regulation of various applications of this powerful technology.
In the feature article in FDLI’s July/August issue of Update magazine, titled “Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,” Hyman, Phelps & McNamara, P.C., attorneys Jay W. Cormier and Ricardo Carvajal provide a common understanding about gene editing and CRISPR and discuss potential applications of the technology as well as regulatory issues in the FDA and USDA arenas.
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- 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
- Does the Drug Shortage White Paper Fall Short? April 9, 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