FDA to take action on companies marketing 'illegal copycat drugs', FDA chief says

The U.S. Food and Drug Administration will take swift action against companies that mass-market "illegal copycat drugs" by ...

House lawmaker raises new concerns over FDA’s ultra-fast drug review program

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
STAT

The FDA wants to rein in drug ads. On Super Bowl Sunday, it will be business as usual

On Super Bowl Sunday, the drug industry is trotting out lounging football stars, a shouting DJ Khaled, and the soothing tones ...

New paper urges caution as FDA plans to phase out animal testing in drug development

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...

US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
The Hill

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 ...
CNN

FDA’s top drug officer set to exit, weeks into new role

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...
Yahoo

Legal questions swirl around FDA's new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
ProPublica

The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. These highlights were written by the reporters and editors ...
Monthly Prescribing Reference

FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs

Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness. HealthDay News — The US Food and ...
Fox Business

FDA rolls back 'red tape' in move aligned with Trump push to speed up new cures

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...
TwinCities.com

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...