STAT

APRIL 30, 2024

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis. In short, this is a so-called carve-out.

Labelling 271

Labelling Generic Medicine Biosimilars 271

Express Pharma

AUGUST 4, 2024

.” Dr Chandrashekar Ranga, Joint Drugs Controller, India, will discuss the obstacles regulators face in the digital era; Dr Stewart Geary, Global Safety Officer, Eisai and a Fellow of DIA, will provide updates on behalf of the Council for International Organizations of Medical Sciences (CIOMS) Working Group XII on Benefit-Risk Balance for Medicinal (..)

Generic Medicine 105

Generic Medicine Labelling 105

pharmaphorum

JUNE 3, 2021

The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its label that includes a claim of less weight gain with olanzapine on its own, a big problem with the widely-used generic drug that affects compliance with treatment.

Adverse Reactions 52

Adverse Reactions Labelling Generic Medicine 52

Express Pharma

NOVEMBER 1, 2024

For instance, the CURE ID platform facilitates collaboration by allowing clinicians to share data on off-label uses of existing drugs,” states Pawar. “As As the world’s largest manufacturer of generic medicines, India has vast potential to utilise repurposed drugs.

Drug Development 111

Drug Development Compounding Generic Medicine Vaccines 111

Quality Matters

APRIL 20, 2023

Quality across the product lifecycle The role of standards goes far beyond the drug manufacturing process – from the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration – to help ensure quality across the pharmaceutical product lifecycle.

Biosimilars 52

Biosimilars Labelling Vaccines Generic Medicine 52

Quality Matters

JUNE 26, 2023

Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. Quality standards in particular help ensure medicines are safe, work as intended, and are available when needed, no matter the company producing them or where they are made.

Dosage 52

Dosage Generic Medicine Labelling 52

Quality Matters

APRIL 26, 2023

Quality standards and related tools – supported by appropriate regulatory capability and enforcement – can help promote quality across the pharmaceutical product lifecycle, from the sourcing of active and inactive ingredients to packaging, labeling, distribution, and point-of-care administration.

Prescription Filling 52

Prescription Filling Generic Medicine Packaging Labelling 52