Agency seeks input on “comparative advantage” requirement for new opioids -
Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more
6/21/2019
/ Applications ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Meetings ,
Regulatory Standards ,
Risk Assessment ,
Rulemaking Process
On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately.
...more
8/16/2018
/ Anti-Kickback Statute ,
Co-payments ,
Drug & Alcohol Abuse ,
Life Sciences ,
Manufacturers ,
New Legislation ,
Opioid ,
Out-of-Pocket Expenses ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State and Local Government
On June 22 the U.S. House of Representatives passed sweeping legislation that represents "the biggest effort Congress has ever undertaken" to address the opioid epidemic, according to Rep. Greg Walden (R-OR). The House...more