eyeonfda

Author of the blog Eye on FDA -

[eyeonfda @eyeonfda]

@US_FDA sets 4/12 #ODAC hybrid #AdComm to discuss use of minimal residual disease (MRD) as endpoint in multiple myeloma CTs - https://t.co/MAlzWsmVqx

[eyeonfda @eyeonfda]

Wow. @US_FDA skeds first hybrid (half in person) human drugs #AdComm for April - an #ODAC meeting - https://t.co/MAlzWsmVqx

[eyeonfda @eyeonfda]

@US_FDA posting revised draft guidance for industry - Early #Alzheimer’s Disease: Developing Drugs for Treatment - https://t.co/l1pTi7E08m #pharma

[eyeonfda @eyeonfda]

@US_FDA officially adding the Digital Health Advisory Committee, originally established in 10/23, expanding the outside expertise advising the agency - https://t.co/L82QeaSCwW

[eyeonfda @eyeonfda]

@US_FDA issues Final Guidance - Charging for Investigational Drugs Under an Investigation #NDA Q&A - https://t.co/Vt00teGOiS #pharma

[eyeonfda @eyeonfda]

@US_FDA announces #Oncologic #AdComm to discuss #NDA for imetelstat for injection for treatment of transfusion- dependent anemia for 3/14/24 - still by video conf and not in person - https://t.co/I5nPNZ0Upi

[eyeonfda @eyeonfda]

@US_FDA #OPDP issues first regulatory action letter of the year - an Untitled Letter - https://t.co/gJti2VfZUE #pharma

[eyeonfda @eyeonfda]

@US_FDA issues guidance - #DTC Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Q &A - https://t.co/qliFn5dHPe

[eyeonfda @eyeonfda]

@US_FDA posts another #OPDP Untitled letter - second day in a row, 5th regulatory enforcement letter of 2023 - https://t.co/X1obW8vHhA

[eyeonfda @eyeonfda]

@US_FDA #OPDP issues Untitled Letter/NOV for overstatement of efficacy in relation to promotion for birth control product - https://t.co/N1yqbU7vSO

[eyeonfda @eyeonfda]

@US_FDA publishing final guidance for #pharma on benefit-risk assessment for new drug and #biologic products to provide clarity on the issue, including how patient experience factors in - https://t.co/rCp867Tk9Y

[eyeonfda @eyeonfda]

@US_FDA #OPDP announced it was going to conduct a new study regarding the role of "adherence" in connection with communicating about a medicine - https://t.co/uRKfw6ZO83

[eyeonfda @eyeonfda]

The summary of activities to continue and staffing plan for @US_FDA during #shutdown - https://t.co/YPMWiwg0jW

[eyeonfda @eyeonfda]

@US_FDA issuing draft guidance - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products replacing 12/29/17 draft - https://t.co/Q6MXkbEXSu

[eyeonfda @eyeonfda]

@US_FDA issuing final guidance - Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies - https://t.co/gLwytYH9iQ #pharma

[eyeonfda @eyeonfda]

@jrovner The same thing just happened to me. His name is Bob. He has his own bedroom.

[eyeonfda @eyeonfda]

@jrovner yes

[eyeonfda @eyeonfda]

@US_FDA scheduling #Pulmonary - #Allergy #AdComm for 11/17/23 to discuss NDA for treatment for chronic cough in adults - https://t.co/pMYGIrtUrn

[eyeonfda @eyeonfda]

@US_FDA announcing Cellular, Tissue, and Gene Therapy AdComm to consider #BLA for #SickleCell on 10/31 - https://t.co/3NM69zoGsc

[eyeonfda @eyeonfda]

@US_FDA issuing final guidance - Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act - https://t.co/fcY5xFJoMC #pharma