Inspections The United States Food and Drug Administration

News & Analysis as of

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

FDA Food Safety Modernization Act Imposes New Requirements on Imported Food

On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (S. 510) (FSMA), which amends the Federal Food, Drug, and Cosmetic Act (the FDC Act). The FSMA shifts the focus of the Food and Drug...more

New Food Safety Law Facing Funding Hurdles

Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the...more

President Obama Signs New Expansive Food Safety Law

In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more

The Food Safety Modernization Act and What It Means to You

The Federal Food Safety Modernization Act passed in the Senate. Right now, bills are going through both the House and Senate that focus upon insuring that the food we buy to eat is indeed safe for all of us. The Senate just...more

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