The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. Cautionary Note on Forward-Looking Statements.

Clinical Trials

Agency IQ

JULY 8, 2024

The court’s decision on June 28 is going to cause a frantic re-evaluation at every regulatory agency in the federal government and in every court in the country. We’re about to find out. Read AgencyIQ’s analysis of the Loper Bright decision ] Unified Agenda: What regulations is the FDA expecting to release through the end of the year?

FDA

Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.”

FDA

Agency IQ

OCTOBER 6, 2023

FDA’s approval volume seems to have recovered from a dip in FY 2022, driven mostly by biologics Now that the government’s – and the FDA’s – fiscal year has come to a close, AgencyIQ has reviewed all novel drug approvals for FY 2023. government fiscal year runs from October 1 – September 30. As a reminder, the U.S.

FDA

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

Agency IQ

JUNE 16, 2023

0910-AH55 December 2023 September 2023 Proposed Rule Clinical Holds in Medical Device Investigations The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. Repeal of this regulation would eliminate an unnecessary policy.

Regulations

The Pharma Data

OCTOBER 15, 2020

Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Shashank joins Trevi from Metrum Research Group where he was senior principal scientist for Clinical Pharmacology. Farrell Simon joins Trevi as head of U.S. eFFECTOR Therapeutics – Premal Patel was named CMO.

Pharmaceuticals