FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

FDA 59

FDA International Production Drugs 59

FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

FDA 52

FDA Regulations Clinical Trials Drugs 52

FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Complaint at 2.

Government 45

Government Compliance Drugs Production 45

FDA Law Blog: Biosimilars

MARCH 5, 2024

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Because the alleged harm arises from the Act, not from the Guidance, the court found that AstraZeneca did not meet the causation or redressability elements of standing under this argument.

Government 64

Government Marketing Production Drugs 64

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.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40