JD Supra17m
State Licensing Requirements: Are You Prepared?
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
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 ...
The American Journal of Managed Care3d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
federalnewsnetwork.com8d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
BioSpace4d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
Supernus: New Approval Holds Promise Of Increased Growth
Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
Verywell Health on MSN9d
Spravato Nasal Spray Can Now Be Used Alone for Treatment-Resistant Depression
People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.