FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. In its 2022 report, GAO recommended that FDA initiate pilot programs that assess unannounced international inspections. Mr. Claud closed his testimony echoing that sentiment.

Testimonials 52

Testimonials FDA International Laboratories 52

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.

Clinical Research 59

Clinical Research FDA Research Clinical Trials 59

Agency IQ

MARCH 1, 2024

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. Was supposed to be finalized as of June 24, 2022. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

FDA 40

FDA Science Biosimilars Regulations 40