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FDA
FDA Draft Guidance on Combination Products
Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance on requesting feedback from the agency related to…
FDA Draft Guidance on Drug Development Tools
The U.S. Food and Drug Administration (FDA) on issued draft guidance explaining its qualification process for drug development…
FDA Releases Draft Guidance on Biosimilar Review
Earlier this month, the United States Food and Drug Administration (FDA) issued new draft guidance on how it plans to expedite its…
FDA and FTC Join Forces on Biosimilar Marketing
Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) released a joint statement about…
FDA and NIH Don’t Always Enforce Clinical Trial Transparency Regulations
Recently, Science magazine reviewed more than 4,700 clinical trials whose results should have been posted on the National…
FDA Announces Plan for Coronavirus Countermeasures
With Coronavirus deaths now over 1,000, the US Food and Drug Administration (“FDA”) announced actions to advance the development…
High Expectations For New Biosimilars About to Hit Market
With recent concerns about the skyrocketing cost of prescription drugs and biologics, attention has turned to whether the…
FDA to End Practice of Quarterly Reports of Approved and Denied Medical…
The US Food and Drug Administration (FDA) proposed revisions to its medical device regulations to end the practice of publishing…
FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness…
The US Food and Drug Administration (FDA) issued draft guidance on demonstrating “substantial evidence” of effectiveness for drugs…
Court Rules FDA Exceeded Authority When It Regulated Contrast Agent As Drug
The US District Court for the District of Columbia recently ruled that the US Food and Drug Administration (“FDA”) exceeded its…