Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. growing drugs in 1,000-liter bioreactors), regulatory limits, and ethical quandaries. Subscribe to Asimov Press.

DNA

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. The draft guidance states that a pre-BLA meeting request should be submitted at least 4 months before the anticipated BLA submission.

Therapies

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

FDA

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development

Agency IQ

JANUARY 26, 2024

Further, other types of coatings or surface modifications are outside of the scope of the guidance – although, notably, the guidance may be able to provide some recommendations about coatings that contain a drug or biologic, but doesn’t “discuss drug or biologic characterization recommendations” – solely the coating material itself.

FDA

Broad Institute

JUNE 27, 2024

Therapy search Vallabh, along with her husband Eric Minikel, leads a lab at Broad focused on developing drugs to prevent and treat prion diseases. From tool to drug Led by Neumann and Bertozzi, the researchers began engineering a new epigenome editor.

Disease

Agency IQ

MARCH 7, 2024

Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates Congressional appropriators this week released the text of the legislation that is set to provide FY2024 funding for the FDA, following a short-term continuing resolution (CR) to fund the agency and related Departments through date.

FDA