Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

OCTOBER 6, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.” The trend of incorporating clinical trial diversity into PMRs continued in FY 2023.

FDA 52

FDA Biosimilars Science Drugs 52

Drug Target Review

DECEMBER 5, 2024

The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders. She is a recognised expert in chromatography and protein purification, and serves as a regular panellist at conferences, seminars, and webinars.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Drug Target Review

MAY 31, 2024

Outside of work, Rachel’s commitment to educational outreach resulted in the conception and organization of a highly successful multi-day medicinal chemistry workshop and the delivery of recurring lectures at the Gordon Research Seminar on Medicinal Chemistry and at Drew University’s Residential School on Medicinal Chemistry.

Organic Chemistry 45

Organic Chemistry Computational Chemistry Small Molecule Disease 45

Agency IQ

AUGUST 23, 2024

Introducing Lias for a plenary at the event, Gutierrez said: “Courtney is in the paperwork for the seminar, she’s put down as the Acting Director. At the NextGenDx Summit in DC this week, former OIVD (as it was then called) Director ALBERTO GUTIERREZ announced that Lias will serve as the Office’s permanent Director.

FDA 40

FDA Laboratories Clinical Trials Regulations 40

Agency IQ

OCTOBER 20, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.”

Science 40

Science Biosimilars FDA Production 40

Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA 40

FDA Science Regulations Production 40

Drug & Device Law

APRIL 16, 2023

DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023 , at the Hilton New Orleans Riverside, in New Orleans, Louisiana. The Seminar is a preeminent program for practitioners who represent pharmaceutical and medical device manufacturers.

FDA Approval 52

FDA Approval Trials FDA Pharmaceuticals 52