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October 6, 2020

How to Tell If the Air Is Safe Enough to Exercise Outside

Share on PinterestSan Francisco faced multiple days of poor air quality in recent months. Artur Debat / Getty Images Smoke from wildfires have left millions of […]
October 6, 2020

Levosimendan Hints at Benefit in Unusual Form of Heart Failure Levosimendan Hints at Benefit in Unusual Form of Heart Failure

An inotropic and vasodilating drug with few clinical-trial victories in heart failure (HF) or other low-cardiac-output conditions showed some limited success in a specific subtype of […]
October 6, 2020

Animal Model Qualification Supporting Documents/Templates

Animal Model Qualification Contacts: Center for Drug Evaluation and Research (CDER)Animal Model Qualification Program TeamEmail:  [email protected]:  301-796-2210 NOTE: Please do not send your qualification submissions to […]
October 6, 2020

Common Cold History Could Confer Some COVID-19 Protection Common Cold History Could Confer Some COVID-19 Protection

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The SARS-CoV-2 virus shares an important feature with some viruses that cause […]
October 6, 2020

DDT COA #000075: Polycystic Liver Disease Questionnaire (PLD-Q)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Hepatology and Nutrition (DHN) DDT COA NumberDDT COA #000075 Instrument NamePolycystic Liver Disease Questionnaire […]
October 6, 2020

DDT COA #000005: Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000005 Instrument NameDiary of Irritable Bowel Syndrome Symptoms- […]
October 6, 2020

Clinical Outcome Assessment (COA) Qualification Program

The CDER Clinical Outcome Assessment (COA) Qualification Program Manages the qualification process for COAs intended to address unmet public health needs. Works directly with requestors in […]
October 6, 2020

Generic Drug Research-Related Guidances & Reports

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new […]
October 6, 2020

Novel Dual-Hormone ‘Artificial Pancreas’ Is Promising Novel Dual-Hormone ‘Artificial Pancreas’ Is Promising

A novel investigational fully automated “artificial pancreas” system that combines rapid-acting insulin aspart (Fiasp, Novo Nordisk) and pramlintide (Symlin, AstraZeneca) performed similarly to a Fiasp-alone hybrid […]
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