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 […]
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 […]
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 […]
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 […]
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 […]
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- […]
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 […]
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 […]
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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