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January 29, 2021

Vaccinating People with High Risk for COVID-19 Isn’t Quickest Way to Herd Immunity

Share on PinterestA new model looks at how we can get to herd immunity more quickly. Genaro Molina / Los Angeles Times via Getty Images A […]
January 29, 2021

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord […]
January 29, 2021

Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

FDA is undertaking a review of active ingredients used in a variety of over-the-counter (OTC) antiseptic rubs and wash products. Health care antiseptics are being evaluated […]
January 29, 2021

Integration of Dose-Counting Mechanisms into MDI Drug Products

This guidance is intended to assist manufacturers who are developing or plan to develop drug products for oral inhalation using metered-dose inhalers (MDIs). The guidance reflects […]
January 29, 2021

Integrated Summary of Effectiveness

This guidance describes the recommended content of the integrated summary of effectiveness (ISE) for inclusion in a new drug application (NDA) or biologics license application (BLA).2 […]
January 29, 2021

Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States – 11/18/2019 – 11/19/2019

On This Page Date: November 18 – 19, 2019 Time: 8:30 AM – 1:00 PM ET Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in […]
January 29, 2021

Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous

Image Español Whether you’re looking to buy weight loss, male enhancement, or certain other products, these days you’re apt to look for them online, rather than […]
January 29, 2021

New Study: COVID-19 Could Damage Sperm, but Experts Query Results New Study: COVID-19 Could Damage Sperm, but Experts Query Results

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. COVID-19 adversely impacts several markers of inflammation and oxidative stress in semen, […]
January 28, 2021

2018 First Generic Drug Approvals

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+ 99 210618 Hydroxyprogesterone Caproate Injection USP, 1250 mg/5 mL (250 mg/mL) Multi-dose […]
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