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- FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs May 25, 2022
- FDA Issues Flurry of Warning Letters Regarding Adulterated Dietary Supplements May 24, 2022
- HP&M’s Sara Koblitz to Present at DC Bar’s FDA for IP Lawyers Webinar May 23, 2022
- Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act May 19, 2022
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Is Advice Provided by Food and Drug Lawyers Legal Advice Protected from Discovery?
April 2, 2007A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice. The court concluded that “[d]ocuments created in the context of seeking FDA approval, an inherently legal process, present ‘a circumstance virtually necessitating legal representation,’ as the FDA approval process requires close supervision by legal counsel.”
Our colleague, John Fleder, wrote in a recent article for FDLI Update that “[t]he Magistrate Judge’s decision was a fundamental ruling on whether food and drug lawyers provided legal advice.” Of course, not all advice provided by food and drug attorneys may automatically qualify as “legal” advice. As such, Mr. Fleder notes that “[t]o maximize the protection of confidentiality, it is important that companies and/or their outside counsel timely document that counsel are rendering legal advice to the client when the purpose of the advice sought is, as it normally should be, legal advice.”
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- A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING Act May 25, 2022
- FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs May 25, 2022
- FDA Issues Flurry of Warning Letters Regarding Adulterated Dietary Supplements May 24, 2022
- HP&M’s Sara Koblitz to Present at DC Bar’s FDA for IP Lawyers Webinar May 23, 2022
- Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act May 19, 2022
- 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