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Regulatory News

FDA Approves First Generic Versions of Celecoxib

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

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Food, Drug & Device Law Alert – FDA Proposes Expedited Approval Program for PMA Medical Devices for Unmet Needs

The FDA recently released a draft guidance document titled “Expedited Approval Program for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life-Threatening or Irreversibly Debilitating Diseases or Conditions.”

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FSMA Gets New Deadlines for Final Rules

The U.S. Food and Drug Administration has reached a settlement with the Center for Food Safety (CFS) and the Center for Environmental Health regarding the deadlines for publishing final rules

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FDA Extends Comment Period on Draft Guidance that Could Require an IND for Cosmetics, Dietary Supplements and Food Research

In September 2013, the FDA issued a draft Guidance titled, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND.”

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FDA Declines Courts’ Requests to Define “Natural” with respect to GMO Foods

Last month, The FDA issued a letter to three federal district court judges declining the courts’ requests to adopt a definition of “natural” or to state whether the terms “natural”

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