Sorensen drug-pricing bill draws criticism from former FDA official

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
AOL

FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
Hosted on MSN

Speeding up approvals, getting more drugs OTC among FDA's top priorities

The FDA is continuing its quest to speed up drug approvals and make more drugs available over the counter (OTC), FDA Commissioner Marty Makary, MD, MPH, said Wednesday. "We want to challenge the ...
RAPS

New Guidance Clarifies Process for Bringing Drugs into US Prior to Approval to Expedite Market Access

A new draft guidance document released by the US Food and Drug Administration (FDA) on 24 July 2013 concerns so-called Pre-Launch Activities Importation Requests (PLAIRs), requests to FDA to allow the ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

FDA Should Stick to Safety

Leaving efficacy to doctors would help Americans lead longer, healthier lives.