Issue 1 JANUARY 2019

The Veeda Newsletter

REGULATORY

FDA ISSUES GUIDANCE TO SPEED APPROVAL OF COMPLEX TRANSDERMAL DRUGS

The guidance is part of the broader FDA Drug Competition Action Plan that was introduced in June 2017 with the intent of increasing competition in the drug marketplace and facilitating entry into the market for lower-cost alternatives.
Read more: https://www.heartland.org/news-opinion/news/fda-issues-guidance-to-speed-approval-of-complex-transdermal-drugs

The Rise Of Use Of Medical Devices Force FDA To Change The Rules

A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community.
Read more :https://www.forbes.com/sites/yiannismouratidis/2018/12/09/the-rise-of-use-of-medical-devices-force-fda-to-change-the-rules/#766e061c2101

FDA Revises Draft Guidance on Developing Drugs for Rare Diseases

The FDA has issued an update to its 2015 draft guidance on developing drugs to treat rare diseases. The new draft guidance, issued last month by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research within the FDA, contains several updates to the original document
Read more at: https://www.ajmc.com/newsroom/fda-revises-draft-guidance-on-developing-drugs-for-rare-diseases


FDA sets records in 2018 in new drug approvals

The United States Food and Drug Administration (FDA) set a record this year in new drug approvals, giving green light to multiple innovative drugs to fight cancers and HIV.
Read more at: http://www.china.org.cn/world/Off_the_Wire/2018-12/31/content_74328075.htm


Looking ahead: FDA priorities for 2019

Since becoming Commissioner of the Food and Drug Administration (FDA) in 2017, Dr Scott Gottlieb has
Read more at: https://www.thepharmaletter.com/article/looking-ahead-fda-priorities-for-2019

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