FDA Reviews Clinical Research Approval Process
November 28, 2018 | FDA | Legislation and Public Policy | Pharmaceuticals

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

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340B Program Changes Finally on the Fast Track
November 6, 2018 | Ada Janocinska | Legislation and Public Policy | Pharmaceuticals

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from

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Kaiser to Present on PLI Panel on Enforcement Trends
November 5, 2018 | Eric D. Fader | False Claims Act | Fraud and Abuse | Medical Devices and Wearables | Pharmaceuticals

On November 16, 2018, Geoffrey R. Kaiser will join the faculty of the Practising Law Institute’s Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries.

Jeff will participate on a panel entitled, “Enforcement Trends Impacting the Drug and Device Industries.” Topics covered will include the False Claims Act, the Anti-Kickback Statute, off-label

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The SUPPORT Act – Supporting Opioid Treatment via Telemedicine
October 23, 2018 | Ada Janocinska | Behavioral Health | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals | Telehealth

On October 3, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The SUPPORT Act is intended to combat the opioid and heroin crisis by reducing use and supply, encouraging recovery, supporting caregivers and families, and driving innovation and long-term solutions. It also includes the expansion

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FTC Slams Stem Cell Therapy Clinic for Deceptive Health Claims
October 23, 2018 | Steven Shapiro | Fraud and Abuse | Litigation | Pharmaceuticals

On October 18, 2018, the Federal Trade Commission (FTC) announced a settlement with a California-based physician and the two companies he controlled. The FTC had alleged that Bryn Jarald Henderson, D.O., and his two companies, Regenerative Medical Group and Telehealth Medical Group, earned at least $3.3 million by offering “stem cell therapy” injections initially costing

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