News from the FDA/CDC
News from the FDA/CDC
Massive rise in drug overdose deaths driven by opioids
The total number of deaths caused by drug overdose exceeded 100,000 for the first time ever in 2021.
News from the FDA/CDC
Alzheimer’s Association to CMS: Ditch restraints on amyloid drugs
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the...
News from the FDA/CDC
FDA puts REMS requirements on hold to ensure continuity of care
The FDA said it will temporarily not object if inpatient pharmacies dispense a days’ supply of clozapine that aligns with a patient’s monitoring...
News from the FDA/CDC
FDA confirms nationwide Adderall shortage
The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.
News from the FDA/CDC
FDA orders Juul to stop selling E-cigarettes
The marketing denial order covers only the commercial distribution and retail sale of Juul’s products and doesn’t restrict consumer possession or...
FDA/CDC
FDA panel rejects pimavanserin for Alzheimer’s psychosis
The FDA will make its final decision by August 4.
FDA/CDC
FDA denies petition to disqualify researchers over controversial ketamine studies
“The FDA denied our petition, and we think that sends the wrong signal to the research community.”
FDA/CDC
FDA okays first sublingual med for agitation in serious mental illness
With a demonstrated onset of action as early as 20 minutes, dexmedetomidine shows a high response rate in patients at both 120-mcg and 180-mcg...
News from the FDA/CDC
As FDA OKs another COVID booster, some experts question need
“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe...
News from the FDA/CDC
Clozapine interrupted: APA, others seek FDA forum on REMS
Clozapine can decrease the neutrophil count, which can lead to severe neutropenia, serious infection, and death.
News from the FDA/CDC
CDC to update mask recommendations as Omicron spreads
“The best mask that you wear is the one you will wear and the one you can keep on all day long,” said Dr. Rochelle Walensky.