Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

FDA Law Blog: Biosimilars

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Production 45

Production FDA Clinical Trials Marketing 45

FDA Law Blog: Biosimilars

JULY 7, 2024

10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] report certain device malfunctions, and. establish and maintain adverse event files.” [9]

Compliance 64

Compliance Laboratories FDA Regulations 64

Drug Hunter

APRIL 24, 2023

A Congressional Budget Office estimates from an earlier version of the act suggest that over the next 30 years, 15 new molecular entites will not make it to market due to the changes in the Inflation Act. Others disagree with the CBO estimate and believe the legislation will have a much greater impact on small molecule NMEs.

Small Molecule 130

Small Molecule Drugs Biosimilars Vaccine 130

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. Nor does it allow for full consideration of the implications of removing PE from the monograph and leaving pseudoephedrine as the only oral decongestant active ingredient that can be used in an OTC drug marketed under the monograph.

FDA 111

FDA Production Pharmacy International 111

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

FDA 71

FDA Marketing Regulations Production 71

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026.

Disease 64

Disease FDA FDA Approval Government 64

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

Disease 52

Disease Therapies Vaccine FDA 52

FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

Judge Jordan asked ACLA for confirmation that he understood correctly that pre-market submission was the major burden for labs and that while pre-market submission compliance dates are still several years away, labs should be preparing now to meet FDAs pre-market expectations. ACLA, of course, confirmed that was true.

Laboratories 102

Laboratories FDA Regulations Compliance 102