Search results for " legislation"
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
New Era for Generic Drugs
8-10
The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the legislation created today’s vibrant generic-drug industry. Generic drugs now account for m…
Article
Prescribing Caution for Biosimilars
… biologic substitution that we believe should be considered by all states when evaluating biosimilar legislation. Briefly stated, these principals are:
•Substitution should occur only when FDA ha…
Article
Managing Biomanufacturing Capacity Expectations
…change in raw material availability, availability of new therapeutic alternatives, or new regulatory legislation.
In a Nature Reviews Drug Discovery study from 2013, investigators concluded that …
Article
Advancing QbD in the EU
It makes clear that this new chapter will also apply to two existing pieces of EU legislation on the principles and guidelines of GMP—one, for medicines for human use, and other, for veterinary applic…
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Biopharma Seeks Balance
The legislation has been criticized as being duplicative of similar laws in individual states, potentially causing unknown harm, conflicting with scientific goals of clinical trials, and undermining t…
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Reimagining Affordable Biosimilars
Although more than 60 years old, this principle is today deeply embedded in all legislation and research methodologies. Recently, a fourth R has been proposed in a white paper by the Max Planck Societ…
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An Analytical Approach to Biosimilar Drug Development
In fact, all of the biosimilars approved in the United States are considered by current legislation to be new biological products without official interchangeability with the reference product. FDA ha…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
A provision in the Cures legislation directs FDA and NIST to collaborate with stakeholders in developing standards for regenerative medicine, and in 2016 NIST formed a public-private partnership with …
Article
Drug Quality Key to Innovation and Access
This patient-centric approach is expected to gain even more support from key provisions in the 21st Century Cures legislation.
These developments raise questions about how much data and what kind …