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The FDA Continues to Crack Down on SARM Manufacturing and Distribution

Following several years of issuing warning letters, the U.S. Food and Drug Administration (FDA) has recently started to investigate and prosecute the people and companies that manufacture and distribute SARMs, or selective androgen receptor modulators. Already, there have been several felony convictions that have put people behind bars for years...

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FDA Counterfeiting Investigations: What Manufacturers and Health Care Providers Need to Know to Avoid Allegations of Fraud

Drug manufacturers have an obligation to secure U.S. Food and Drug Administration (FDA) approval before distributing their products in the United States, and health care providers have an obligation to ensure that they are only prescribing and dispensing FDA-approved drugs. When counterfeit ingredients and drugs enter the market, the risks...

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FDA Warning Letters (Overview & Response Strategies)

The U.S. Food and Drug Administration (FDA) is tasked with enforcing several federal laws, most notably the Food, Drug, and Cosmetic Act (FD&C) and certain parts of the Public Health Service Act. The scope of these laws is massive, so the FDA has had to rely on less conventional enforcement...

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How to Prepare for an FDA Inspection Audit: 7 Steps

The U.S. Food and Drug Administration (FDA) does much more than approve foods and drugs for sale. Among other mandates, it is also tasked with enforcing companies’ obligations under the Federal Food, Drug, and Cosmetic Act and other sources of authority, and it is extremely active in its enforcement efforts....

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