Clinical Research Solutions
Ulcerative Colitis: Developing Drugs for Treatment
Guidance Document April 2022. The purpose of this guidance is to help sponsors in the clinical development of drugs to treat adults with ulcerative colitis (UC). This guidance addresses the Food and...
Clinical Research Solutions
Drug Products, Including Biological Products, that Contain Nanomaterials
Guidance for Industry April 21, 2022 Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.3 Nanotechnology...
Clinical Research Solutions
Providing Submissions in Electronic Format — Postmarketing Safety Reports
GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...
Clinical Research Solutions
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
April 25, 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at...
Clinical Research Solutions
FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations
FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...
Clinical Research Solutions
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
March 29, 2022 Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain...
Clinical Research Solutions
FDA Announces OTC Monograph Drug User Fees for Fiscal Year 2022
Monday, March 14, 2022 Today, the U.S. Food and Drug Administration announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice...
Clinical Research Solutions
FDA’s Breakthrough Therapy Designation vs PRIority MEdicines (PRIME) Application in Europe
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
Regulatory Sciences
European Expedited Regulatory Programs Explained
Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...
Clinical Research Solutions
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...