Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 20 December 2017 | By Zachary Brennan
From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published.
10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies
Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.
The review of medicines studied by Micro Therapeutic Research Labs was begun after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016.
And in June, the European Commission issued its implementing decision regarding the marketing authorisation applications and marketing authorisations of medicinal products for human use for which clinical and/or bioanalytical parts of the bioequivalence studies were performed at Micro Therapeutic Research Labs.
9. A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker
In May, FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker, which was the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
Since the approval, FDA has issued guidance seeking to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases.
8. FDA to Recognize 8 EU Regulators to Conduct GMP Inspections
FDA in October announced it will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug manufacturing inspections worldwide.
7. FDA to Create Digital Health Unit
In May, Bakul Patel, associate center director for digital health at FDA, told attendees at MedCon in Cincinnati of a new digital health unit that was coming in CDRH’s Office of the Center Director. Since the announcement, nine companies, including Apple, Fitbit, Roche, Samsung and Google’s Verily, were selected to be part of a pre-certification digital health pilot project evaluating different types of software programs that straddle the line between being medical device and app.
FDA will hold a public workshop 30-31 January 2018 to report on and review its initial findings from the pilot project.
6. FDA Approves First Generic Version of Gilead's HIV Drug Truvada
The approval of a first generic competitor to Gilead’s blockbuster HIV drug attracted a lot of attention. In 2017, FDA has approved 74 first-time generic drugs.
5. Final Versions of EU MDR, IVDR Released
The European Council released the final texts of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR).
4. 6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation
Almost 10,000 readers tuned into RAPS Executive Director Paul Brooks in June, who explained to readers how to begin preparations for the EU’s new Medical Devices Regulation (MDR), which entered into force in May, setting in motion a three-year countdown to the new rules’ full application in 2020.
3. Biosimilar Interchangeability Draft Guidance From FDA
In January, FDA released draft guidance on what an interchangeable biosimilar means. Since then, commenters have weighed in on the draft, and FDA’s top biosimilar official said the first interchangeable biosimilar may hit the US market in the next two years.
2. FDA Approves 5th Biosimilar, 2nd for Remicade
Samsung and Merck won approval for the second Remicade biosimilar, Renflexis (infliximab-abda), which came to the US market in July. Earlier this month, Pfizer also won approval for another Remicade biosimilar, known as Ixifi (infliximab-qbtx), though the company said it will not launch it in the US.
1. Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated
2017’s top story for Focus – read by more than 50,000 – featured a grandiose claim from President Donald Trump that, at least so far, has not proven to be accurate.
Tags: biosimilars, Labs, Micro, Research, Therapeutic, Trump, Truvada