ISSUE 5 : MAY 2019
The Veeda Newsletter
REGULATORY
In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February 2019 draft International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines have changed or are poised to change the landscape of outsourcing bioanalysis to support drug development.
Read more:
http://www.pharmtech.com/impact-new-fda-guidance-bioanalytical-testing-drug-development
The US Food and Drug Administration created a workaround this week that effectively undercuts the $375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry.
Read more : https://www.fox10tv.com/news/us_world_news/fda-undercuts-drug-in-surprise-move/article_54c39b02-d7dc-50bc-82ad-60ba5f9bcf3a.html
The US Food and Drug Administration (FDA) on Thursday finalized guidance to help drug sponsors determine when they should submit an abbreviated new drug application (ANDA) for a generic or a 505(b)(2) application for a drug that partly relies on certain data from an already-approved drug.
Read more : https://www.raps.org/news-and-articles/news-articles/2019/5/when-to-submit-an-anda-vs-a-505b2-fda-explai
Need a new brand name if composition of drug is changed: Pharma regulator
According to a notification issued on Thursday by the CDSCO, the practice of changing the key therapeutic ingredients in a drug formulation without changing the brand name "is not only misleading but may also result in undesirable pharmacological effects as the consumer would take the formulation assuming that it has the earlier composition."
Read more : https://indianexpress.com/article/business/economy/central-drugs-standard-control-organisation-pharma-regulator-drug-controller-of-india-5731908/
Interchangeable Biosimilars: FDA Finalizes Guidance
The US Food and Drug Administration (FDA) on Friday finalized a long-awaited guidance spelling out how biosimilars can achieve an interchangeable status, which means they may be substituted for the reference biologic without a prescriber intervening.
Read more : https://www.raps.org/news-and-articles/news-articles/2019/5/interchangeable-biosimilars-fda-finalizes-guidanc
