Posted 23 December 2016
By Zachary Brennan
Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading!
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers: A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs.
Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017: Pfizer’s blockbuster will start to lose its market share in the new year.
New ISO 13485: Device Companies Have Three Years to Transition: This long-awaited revision to ISO 13485, the global standard for medical device quality management systems, updates the previous version from 2003.
Brexit Conundrum: How Does MHRA Work With EMA Moving Forward: With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.
Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA: A massive new law that will have implications for both the drug and device industries.
What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies: The impact of the incoming administration will be felt in 2017, particularly as the new user fee programs need to be reauthorized.
Regulatory Explainer: Everything You Need to Know About Biosimilars: As more biosimilars make their way from pipeline to market, this rundown of the current landscape may come in handy in 2017.
EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations: With implementation beginning in 2017, Focus will look to report on aspects of the new legislation that will cause the most headaches for industry.
Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance: With the rise of data manipulation and other data integrity questions in India, China and elsewhere, FDA is trying to help the pharma industry make sure data is consistent and accurate.
FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices: New ideas on both the device and pharma ends will likely continue to shape FDA guidance in 2017 and beyond.