This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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.
.” 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 (..)
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.
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 genericmedicines, India has vast potential to utilise repurposed drugs.
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.
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.
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.
With this extensive system in place, patients can trust that medicines with the same name will be consistent in quality no matter who manufactures it or where in the world it is made. Since manufacturers know the precise quality specifications, standards help make the approval process for genericmedicines more efficient.
It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.
This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.
These include allowing the exceptional supply of certain medicines that may not be authorised in a particular Member State or granting full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of some medicines.”
Certain groups of individuals may then not trust that the medicines have been produced with them in mind and may be highly sceptical of the resulting evidence base and prescribing label of medicines. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and genericmedicines.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content