AG/FDA Blog

The Realized Benefits of User Fees

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to sha… Read More
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Thirty Years of Hatch Waxman

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues aris… Read More
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Hatch-Waxman Turns 30 – A Stroll Down Memory Lane

Happy Birthday, Hatch-Waxman! You’re a mature 30-year old now, a regular adult. Some personal musings on my stroll down the Hatch-Waxman Memory Lane over the past 30-plus years follow. A small background digression: For those of you in the FDA regu… Read More
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FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic drugs with labeling that “carves-out” information protected by a brand drug’s patents or marketing exclusivity. Se… Read More
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Act 2, The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research – Is this the Spoonful of Sugar?

Today, FDA announced that it has decided to reopen, for 60 days, the comment period for certain parts of its controversial final guidance, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Condu… Read More
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The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research

“Let food be thy medicine and medicine be thy food.” So Hippocrates, the father of medicine, stated. Unfortunately, the Food and Drug Administration (FDA) has taken Hippocrates too literally, with immediate and severe consequences to food and nut… Read More
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Mirror, Mirror on the Wall: Nothing Magical about FDA Warning Letters for Cosmetics with Age-Related Claims

The evil queen sucks the life out of young maidens to sustain her flawless complexion in the movie Snow White and the Huntsman. If you are wondering how the U.S. Food and Drug Administration (FDA) might regulate the claims for a product with such reg… Read More
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OFW Law Drug and Health Care Privacy Practices

OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health… Read More
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