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October 13, 2021

Pandemic Data Challenges Infection Link to Guillain-Barré Pandemic Data Challenges Infection Link to Guillain-Barré

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Armed with pediatric data from the COVID-19 pandemic, a team of researchers […]
October 13, 2021

‘Fascinating’ Link Between Alzheimer’s and COVID-19 ‘Fascinating’ Link Between Alzheimer’s and COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Risk for Alzheimer’s disease (AD) and susceptibility to severe COVID-19 share a […]
October 13, 2021

FDA OKs Gender-Neutral Language for Isotretinoin iPLEDGE Program FDA OKs Gender-Neutral Language for Isotretinoin iPLEDGE Program

The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients. Beginning on Dec. 13, […]
October 13, 2021

FDA OKs iPLEDGE Change for Gender-Neutral Language FDA OKs iPLEDGE Change for Gender-Neutral Language

The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients. Beginning on Dec. 13, […]
October 13, 2021

HHS Okays Pilot to Mandate Coverage of Gender-Affirming Care HHS Okays Pilot to Mandate Coverage of Gender-Affirming Care

The US Department of Health and Human Services (HHS) has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care. The […]
October 13, 2021

Agencies Moving Biden’s Vaccine Order Forward Agencies Moving Biden’s Vaccine Order Forward

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The Biden administration’s COVID-19 vaccine mandate for employers moved a step closer […]
October 13, 2021

Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS

Submit Comments by 12/13/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
October 13, 2021

New FDA Guidance Aims to Cut Sodium in Processed Foods New FDA Guidance Aims to Cut Sodium in Processed Foods

The US Food and Drug Administration (FDA) has issued voluntary, short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for processed, packaged, and […]
October 13, 2021

New Approval in Early Breast Cancer: First Advance in 20 Years New Approval in Early Breast Cancer: First Advance in 20 Years

The CDK4/6 inhibitor abemaciclib (Verzenio) has been approved for use in early breast cancer for certain patients. One expert has described the drug as the first […]
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