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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. Mr. Bawduniak claimed that these events were held at “sumptuous resorts and restaurants” and involved “lavish meals and free alcohol.”

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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law

HP&M is proud to have our professionals participating in these important events. We can offer our readers a special discount for the event. On March 20-21, Counsel John W.M. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

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15 Years Strong: Rare Disease Week’s Remarkable Journey of Support

FDA Law

What started as a day has — due to its popularity and the persistent efforts of patients and industry — evolved into a week-long event. And my support and pride continue since we now see a host of programs and events the last week of February playing out around the world.

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ACI’s 23rd Advanced Summit on Life Sciences Patents

FDA Law

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

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Agitation Podcast Series Episode 3: Pharmacologic management of agitated children

PEMBlog

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. Qualitative study of patient experiences and care observations during agitation events in the emergency department: implications for systems-based practice. 2022 May 11;12(5):e059876. doi: 10.1136/bmjopen-2021-059876.

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ACI’s Advanced Legal, Regulatory and Compliance Forum on OTC Drugs, January 23?–?24, 2024, New York, NY — Featuring HPMer and Former FDAer Deborah Livornese

FDA Law

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. The discount code is: S10-826-826L24.S.