- 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
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Latest FDLI Update Magazine Article Explains DEA Preregistration and Cyclic Inspections
December 13, 2017By Larry K. Houck —The Drug Enforcement Administration (“DEA”), in response to the nationwide controlled pharmaceutical diversion and abuse crisis, now conducts more frequent regulatory inspections in greater depth to identify registrants who violate the Controlled Substances Act and implementing regulations. In addition to inspecting and auditing manufacturers, distributors, importers, exporters, and narcotic treatment programs, DEA diversion investigators now inspect pharmacies, hospitals and practitioners. These were registrants that historically had not been subject to scheduled inspections. Registrant noncompliance disclosed during a DEA inspection can lead to significant administrative, civil and even criminal consequences.
Hyman, Phelps & McNamara, P.C. attorney Larry K. Houck, a former DEA diversion investigator, authored an article that appears in the latest issue of the Food and Drug Law Institute’s “Update” magazine. The article, titled “DEA Preregistration and Cyclic Inspection: What Applicants and Registrants Must Know in the Prescription Opioid Epidemic Age,” explains what applicants and registrants must expect during DEA inspections in the current regulatory climate.
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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