FDA Law Blog: Biosimilars

MARCH 29, 2024

In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. But gaps still remain. These positions suffer from high turnover due to low pay and frequent travel.

Clinical Research 59

Clinical Research FDA Research Clinical Trials 59

Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

Government 40

Government FDA Biosimilars Regulations 40

FDA Law Blog: Biosimilars

APRIL 8, 2024

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections.

Drugs 59

Drugs FDA Hospitals Government 59

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely). the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40