Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

Biosimilars 40

Biosimilars FDA Production Licensing 40

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. had Grade 3 or 4, and no fatal cases were reported.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.” We, and many stakeholders, agree that RWD and RWE can play an invaluable role.

FDA 109

FDA Production Trials Pharmacy 109

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The practical consequence of adding these words is that LDTs are expressly defined as a type of IVD device, and subject to device regulations, including registration and listing, premarket review, post-market reporting, and quality system regulation. direct-to-consumer tests, tests for use in a public health emergency).

Laboratories 62

Laboratories FDA Regulations Production 62

FDA Law Blog: Biosimilars

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

Government 62

Government Marketing Production Drugs 62

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 44

Production FDA Clinical Trials Marketing 44

Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

Regulations 40

Regulations Clinical Trials Production Trials 40