Clinical Research Solutions
FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments
Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This guidance describes the benefit-risk principles applied by FDA...
Clinical Research Solutions
Implementation of ICH E2B(R3)
April 2022 Guidance Document E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide...
Clinical Research Solutions
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability
May 2022 Guidance Document Download the Final Guidance Document The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of...
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
2020 Trends in Biopharma
COVID-19 has been the ultimate Big Pharma catalyst, as well as the biggest thing to hit biopharmaceutical news pages in decades. On the industry side, however, investors and observers remain mindful...
Clinical Research Solutions
9 Medical Writing Mistakes to Avoid
With around 2.5 million scientific papers published every year, it is impossible for medical professionals to keep up with all the latest research. Every piece of content is fighting for eyes. To...