FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

52

52

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

pharmaphorum

SEPTEMBER 30, 2022

An open-label extension revealed that ALS patients had around six more months before being hospitalised, requiring a ventilator or dying compared to the control group and, according to Amylyx, patients who continued taking the drug survived about 10 months longer. . — The ALS Association (@alsassociation) September 29, 2022.

Specialty Pharmacies 98

Specialty Pharmacies Labelling Hospitals Drug Development 98

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author. About the author.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014. The Role of Master Protocols in Pediatric Drug Development. Ther Innov Regul Sci.

Compounding 59

Compounding Labelling Drug Development 59

Pharmaceutical Technology

JUNE 12, 2023

However, side effects known as amyloid-related imaging abnormalities, which often involve brain swelling, were also reported, and consequently the treatment has a warning on this specific side effect on its label. Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease.

Medical Schools 52

Medical Schools Labelling Drug Development 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. The worldwide trend of using botanical drugs and strategies for developing global drugs.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103