The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
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3/25/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Regulatory Oversight ,
REMS
On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic routine surveillance facility...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
3/11/2020
/ China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Inspections ,
Manufacturers ,
Pharmaceutical Industry ,
Policy Statement ,
Public Health ,
Risk Management ,
Screening Procedures ,
Supply Chain
On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more
4/26/2019
/ Biotechnology ,
Draft Guidance ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Medical Devices ,
Pharmaceutical Industry ,
Product Recalls ,
Regulatory Oversight ,
Strategic Planning