- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
- Are Predetermined Change Control Plans on the road to Global Harmonization? November 30, 2023
- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
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Whistleblowers: A Potential Problem for Everyone
July 15, 2010In the May/June 2010 edition of FDLI Update, HP&M Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves.” The article addresses various issues that companies face when they are confronted with employees who raise complaints within a company about its compliance with regulatory requirements. The article discusses how one company benefitted from having generated contemporaneous documents that refuted allegations that a company employee (and potential whistleblower) had made about the company's alleged failure to comply with FDA-related requirements. The article also discusses the current government enforcement environment in which a large percentage of cases brought these days are based on whistleblower complaints. Finally, the article provides a number of practical suggestions for companies with regard to their treatment of potential and actual whistleblowers.
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- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
- Are Predetermined Change Control Plans on the road to Global Harmonization? November 30, 2023
- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 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