Search results for " approval" in Articles / App Notes
Article
EMA Collaborates with HTA Assessment Networks
This approval can be either by the central London-based European Medicines Agency (EMA) for a product to be marketed across the region or by a national licensing authority for one to be sold only in s…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“The FDA has been talking about this approach for awhile, meaning they’ll look at the approval of biosimilars as a compilation of all of the evidence and characterization that a company has developed …
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Reimagining Affordable Biosimilars
Furthermore, adequate process controls to monitor and control product quality are necessary for receiving regulatory approval. Ultimately, this situation creates a burden on the manufacturer to invest…
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The Outlook for CMO Outsourcing in 2019
FDA approved approximately 25 new biopharmaceuticals in 2018 (1), and the number of annual approvals is expected to increase in coming years, as new classes of products receive approvals, particularly…
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Drug Discovery and Development in India
Pachhapur says, “The clinical-trial segment also faces challenges such as regulatory uncertainty regarding conduct of trials, unethical practices, and approval delays.” It is estimated that it takes o…
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Labeling of Biosimilars
A revised overarching guideline (2) on the basic principles governing the approval of biosimilars is due to be implemented in April 2015. It includes a provision that authorization of a biosimilar in …
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
In the EU, the market approval of a generic or biosimilar drug is not dependent on the patent status of its branded equivalent. Consequently, generic and biosimilar companies are able to launch "at ri…
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Driving Improved Access to Biosimilars
So far, Boehringer-Ingelheim has been the only company to have pursued a US strategy that combines basic biosimilar approval and approval for interchangeability for its adalimumab (Humira) biosimilar,…
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CoAs Help Secure the Supply Chain
It should also have the identity and signature of the person who approved the certificate along with the date of approval. The World Health Organization (WHO) has a document on their website titled, “…
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Vaccine Development Faces Urgency and Challenges
The campaign has helped move more vaccine candidates through clinical testing to market approval, according to an analysis in the February 2016 special issue on vaccines in the journal Health Affairs …