FDA and CDC Lift Recommended Pause on Janssen Vaccine Use Following Thorough Safety Review

Based on confidence in vaccine’s safety and effectiveness following data assessment

  • Vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older
  • Chance of clots is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk
  • Fact Sheet for Recipients and Caregivers, provide information on risk


COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention

Guidance describes current recommendations regarding phase 2 and phase 3 trials for drugs under development to treat or prevent COVID-19

  • Population
  • Trial Design and Conduct
  • Efficacy Endpoints
  • Safety Considerations
  • Statistical Considerations


A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response

Pharmacometric models based on recurrent neural network to simulate the time course of pharmacodynamic (PD) response that develops latently, according to complex biological intermediate step

  • A long short-term memory recurrent neural network (LSTM RNN) trained to use time sequence of simulated plasma concentrations along with patient baseline PD values and patient demographics to predict PD response in single dose regimen
  • Machine Learning model able to accurately predict the PD response of individuals who were treated with different dosing regimens
  • LSTM RNNs may complement traditional PK/PD models in the area of highly complex PK/PD data analysis and possibly facilitate development of predictive models with improved accuracy.  


Efforts to ban menthol cigarettes to reduce addiction and youth experimentation, improve quitting, and address health disparities

Two tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars

  • Menthol masks unpleasant flavors and harshness of tobacco products, more addictive and harder to quit
  • Banning menthol cigarettes would lead an additional 923,000 smokers to quit, including 230,000 African Americans, avert 633,000 deaths including about 237,000 for African Americans


CDRH Patient Science and Engagement

CDRH puts patients first with its Patient Science and Engagement Program

  • Communicating COVID-19 testing to underrepresented populations
  • Gender differences for heart failure Patient-Reported Outcome measure
  • Ranking factors influencing women’s decision making on uterine fibroids surgery decision making
  • Workshop of Patient-Generated Health Data and its use across the healthcare ecosystem and during medical device development, evaluation, and monitoring


Critical Importance of Safe Disposal of Opioids  

Unused or expired medicines in the home have long been a major safety concern and implicated in most some common and most severe cases of accidental ingestion by children

  • Removing prescription opioids once no longer medically necessary can prevent accidental exposure or intentional misuse
  • Access drug take back site, check if a drug is on the  “flush list
  • FDA exercises oversight on packaging and disposal of drugs that pose risks of abuse or overdose, such as opioid analgesics
  • Take advantage of the National Prescription Drug Take Back Day 

Where and How to Dispose

Colorectal Cancer Screening Options

The only way to find a polyp, precancerous growth, or colorectal cancer is to do a screening test or procedure

  • FDA authorized Colorectal Cancer Screening: Stool sample tests (at-home stool test) and Visual screening procedures (colonoscopy, Flexible Sigmoidoscopy, CT Colonography)
  • Some Minority Groups Are at Higher Risk: Black men and women as well as American Indian and Alaska Native people
  • Colorectal Cancer Rates Are Up Among Adults Under 50


Image credit: FDA, CDC