Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration (“FDA”) or the Centers for Medicare & Medicaid Services (“CMS”) should be aware that the U.S. Department of Health and Human Services (“HHS”) is increasing the maximum civil monetary penalty amounts that may be assessed by the
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HHS Increases Civil Monetary Penalties and 299 Other Fines
New FDA Draft Guidance Shows Limited Compromise with Brand and Generic Drug Manufacturers
New FDA Draft Guidance Shows Limited Compromise with Brand and Generic Drug Manufacturers
FDA Rule Providing Generic Manufacturers with the Ability to Unilaterally Update Safety Labels May be Abandoned
FDA Rule Providing Generic Manufacturers with the Ability to Unilaterally Update Safety Labels May be Abandoned
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