Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
NC Biotech

Charlotte’s Milestone Pharmaceuticals gains FDA approval for heart drug

Milestone Pharmaceuticals, a Canadian company with a U.S. subsidiary in Charlotte, is starting the new year with its first ...
BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...