article thumbnail

STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period

STAT

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
article thumbnail

DIA’s India Annual Meeting to host discussions on evolving regulatory landscape

Express Pharma

.” 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 (..)

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

pharmaphorum

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.

article thumbnail

Drug Repurposing: Unlocking access to rare solutions

Express Pharma

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.

article thumbnail

Standards support medicines supply chain resilience and the future of quality

Quality Matters

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.

article thumbnail

Complex generics: Are global regulators addressing the needs?

Quality Matters

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
article thumbnail

Essential elements of a strong, global medicines supply chain

Quality Matters

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.