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Human Drugs

Improve and Pass H.R. 3: Public Citizen

Public Citizen calls on the House to improve H.R. 3 to lower drug prices and then pass the legislation.

Human Drugs

Some Post-Approval Studies Need a Long Time: Opinion Post

Forbes contributor John LaMattina defends the long time needed to complete some drug post-approval studies.

Human Drugs

Doctor Sues FDA Over Internet Abortion Drugs

A Dutch physician sues FDA in Idaho federal court after the agency seized several international packages containing abortion drugs that were addressed...

FDA General

Act on Vaping or Resign, Durbin Tells Sharpless

Senator Richard Durbin (D-IL) urges FDA acting commissioner Ned Sharpless to take immediate action to curb the e-cigarette and vaping epidemic or resi...

FDA General

FDA Rolling Out IT Modernization Plan Shortly

FDA acting commissioner Ned Sharpless says the agency is just weeks away from announcing a new plan to modernize its technology infrastructure to help...

Human Drugs

FDA Denies Petition Seeking New Opioid Moratorium

FDA denies a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on approval of any new ...

Medical Devices

2 FDA Guidances on De Novo Device Requests

FDA issues two guidances related to medical device de novo classification requests one on performance goals and the other on user fee refund requests...

FDA General

FDA Hits Juul with Warning Letter

FDA issues a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products.

Human Drugs

FDA Quality Guide on Real World Data Coming

FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations.

Human Drugs

GAO Report on Patient Access to Investigational Drugs

A new GAO report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could broaden clinical tria...