PharmTech Talk

Sep 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Aug 28, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Aug 02, 2018
Pharmaceutical Technology
More consistent and reliable production processes are critical for advancing innovative treatments.
Jul 23, 2018
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
Jul 02, 2018
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Jul 02, 2018
Pharmaceutical Technology
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jun 20, 2018
Pharmaceutical Technology
Legislators have requested that FDA do more to prevent drug shortages.
Jun 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
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