Conversations in Drug Development Trends

FEBRUARY 22, 2023

I joined the FARA staff in 2009, and our team built a nationwide series of bike rides called rideATAXIA to raise funds for research. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

Disease 52

Disease Clinical Trials Trials Treatment 52

PLOS: DNA Science

APRIL 4, 2024

Among the barrage of drug ads for cancer, diabetes, weight loss and more are those for Lume , a “doctor-developed whole body deodorant.” The earliest patent I found was issued in late 2009, for “Products and Methods for Reducing Malodor from the Pudendum.” ” For everyone. .” ” Lady parts.

Disease 88

Disease Testimonials Production FDA 88

Drug Target Review

JUNE 29, 2023

It set a precedent with regulators as to what is expected in some instances. Success in the haematology space has really been driving this from the beginning, which is not surprising as haem doctors understand stem cell transplants; they’re used to working with a lot of the sort of toxicities that can come with cell therapies.

Therapies 115

Therapies Science Production Cell Biology 115

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.

FDA 52

FDA Pharmaceutical Companies Doctors Regulations 52

Drug & Device Law

APRIL 14, 2023

As readers know, FDA reviews Class II devices for “substantial equivalence” to devices that are on the market. But, during FDA’s review process, the agency decided that the device was not “substantially equivalent” to devices that were on the market. internal punctuation and citation omitted). New York Stock Exchange, Inc. ,

FDA 59

FDA Doctors Regulations FDA Approval 59