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 Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
2/22/2019
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Agenda ,
Regulatory Oversight ,
Reversal
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more