Track topics on Twitter Track topics that are important to you
Combination products remain one of the most difficult regulatory challenges for life sciences innovators. Drug or Device? How the 21st Century Cures Act Impacts Combination Products offers practical advice on the newest changes in the law on combination products and a look around the corner at how sponsors of combination products should seek to position their products to ensure a least burdensome and optimal regulatory pathway.
Falls Church, VA (PRWEB) June 30, 2017
Combination products remain one of the most difficult regulatory challenges for life sciences innovators.
Which FDA Center has the lead?
Will the product need one marketing application or two?
Will a drug need to be cross-labeled and approved for use with a device?
These and many more questions can make combination product sponsors feel like they are entering an unforgiving regulatory labyrinth.
The 21st Century Cures Act requires the FDA, over the next several years, to issue guidance that will create a structured process and best practices for managing the development and reviews of drug/device/biologic combinations. The law provides for a streamlined approach to GMP for combination products similar to what the agency has recently announced through rule and guidance.
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. Readers will learn:
Order Drug or Device? How the 21st Century Cures Act Impacts Combination Products for practical advice on the newest changes in the law on combination products and a look around the corner at how sponsors of combination products should seek to position their products to ensure a least burdensome and optimal regulatory pathway.
Who Will Benefit:
FDAnews Management Report Details:
Drug or Device? How the 21st Century Cures Act Impacts Combination Products
Easy Ways to Order:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/drugordevice/prweb14468763.htmNEXT ARTICLE
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...