The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more
President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to...more
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
3/6/2020
/ Biologics ,
Biotechnology ,
Clinical Laboratories ,
Clinical Trials ,
Data Collection ,
Data Management ,
Department of Health and Human Services (HHS) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Generic Drugs ,
Informational Studies ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Research and Development
The Agency improves the process for access to investigational drugs and biologics for patients who lack other options.
On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more