Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
MedPage Today23d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
In light of this, the OIG examined the FDA's decision-making process in a sample of 24 accelerated drug approvals. Of the 24 drugs, three approvals deviated from the others -- aducanumab ...
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Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's ... process. However, drugmakers whose treatments are granted accelerated approval are required to conduct postmarketing trials to confirm the drug's benefit ...
JD Supra26d
Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110
Our FDA/Food, Drug ... in-process sampling Process monitoring and control decisions that result in minor equipment and process adjustments do not need additional quality unit approval under ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The FDA approved a pain drug designed to eliminate the risks associated with opioids -- the first new pharmaceutical approach ...