News & Analysis as of

Medicare Prescription Drug Improvement and Modernization Act (MMA)

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

New OIG Exclusion Regulations About to Go into Effect

by McDermott Will & Emery on

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Blog: OIG Issues Final Rule Re: Exclusion Authority

by Cooley LLP on

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare...more

HHS OIG Finalizes New Exclusion Rules as Administration Exits

by Hogan Lovells on

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

by Morrison & Foerster LLP on

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

FTC Announces Substantial Increases to Civil Penalties

by White & Case LLP on

On Wednesday, June 29, the Federal Trade Commission (FTC) announced substantial increases to the maximum civil penalties for 16 distinct violations of certain laws enforced by the FTC. Notable increases were announced for...more

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