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The filing came just days after the FDA and EMA announced they are investigating the drug after learning that it contained low levels of the impurity. Read More
The FDA urges trial sponsors who may be thinking of using Bayesian statistics in complex innovative trials to consider alternatives, in a new draft guidance issued Monday. Read More
Senior FDA officials promised “flexibility” to help address the unmet medical need as the agency released final guidance on Monday for sponsors of treatments for amyotrophic lateral sclerosis (ALS) — Lou Gehrig’s disease. Read More
Americans pay on average nearly four times more for prescription drugs than citizens in comparable countries, the House Ways and Means Committee claims in a report released on Monday. Read More
The DEA is seeking public comment from legitimate industries that use the substance and the potential burden the proposed regulatory controls may have on their activities. Read More
Kashiv claimed that the patents are obvious to anyone with at least a bachelor’s degree or equivalent in biochemistry or chemical engineering. Read More
The agency said it extended the deadline to “minimize impacts on the industry and help ensure continued market access for transitioning listed medicines.” Read More