Note -
On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
1/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Agricultural Sector ,
Appropriations Bill ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Drug Approvals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Popular
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
6/8/2018
/ Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Drug Approvals ,
Drug Design ,
Drug Safety ,
Drug Testing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Recruitment Incentives ,
Regulatory Reform ,
Trump Administration
On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more
9/19/2017
/ Congressional Committees ,
Discussion Draft ,
Drug Approvals ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Reform
The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more