The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more
6/29/2022
/ Audits ,
Clinical Trials ,
Compliance ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Prescription Drugs ,
Regulatory Violations ,
Research and Development ,
Sponsors ,
Warning Letters
For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more
The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages...more
Developing a new drug or biologic is a complex process. Based on our extensive experience advising early-stage and clinical-stage companies, the Goodwin FDA team created this “scorecard” for companies to use as a guide as...more
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more
Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more
4/8/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health ,
Relief Measures ,
Supply Chain
As the COVID-19 pandemic unfolds, our drug, biologic, and medical device clients conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or...more
With the “patient experience” becoming an increasingly important element in directing not only where industry spends its limited drug development resources but how clinical trials are designed, the U.S. Food and Drug...more
This client alert provides background on two recent developments related to patient access to investigational therapies outside of the clinical trial setting: expanded access and right-to-try. First, we discuss a fairly new...more
On April 12, 2018, the U.S. Food and Drug Administration (FDA) announced the finalization of two guidances that describe regulatory approaches intended to streamline oversight of next generation sequencing (NGS)-based tests...more