Regulatory Focus Articles
Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?
Fri, 16 Aug 2019 20:05:53 GMT
A quick look at biopharma’s top-selling drugs (including forecast sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion.
MDIC Kicks Off Framework on Patient Input in Device Trials
Fri, 16 Aug 2019 19:59:50 GMT
The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year.
 
Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger
Fri, 16 Aug 2019 18:33:05 GMT
Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA).
Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq
Fri, 16 Aug 2019 18:06:27 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?
Fri, 16 Aug 2019 15:58:15 GMT
The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.
FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment
Thu, 15 Aug 2019 20:36:04 GMT
The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments.
 
Growing Numbers of Priority and Competitive ANDAs Under Review as Approvals Trickle In
Thu, 15 Aug 2019 20:09:46 GMT
The US Food and Drug Administration (FDA) on Wednesday released quarterly data on two of its programs aimed at increasing generic competition and speeding the approval of priority generic drugs.
Drugmakers Seek US, EU Harmonization on NASH Drug Development Guidance
Thu, 15 Aug 2019 20:06:45 GMT
Novartis, Gilead, Regeneron, Novo Nordisk, Boehringer Ingelheim and others recently told the US Food and Drug Administration (FDA) to better align its draft guidance on drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis with the European Medicines Agency (EMA).
 
Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices
Thu, 15 Aug 2019 18:27:09 GMT
With an eye on post-Brexit drug and medical device shortages, the UK’s Department of Health and Social Care said Thursday that it’s established a £25 million contract to set up a 12-month express freight service to deliver medicines and medical products into the country.
Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit
Thu, 15 Aug 2019 17:29:15 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
EU Regulatory Roundup: UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit
Thu, 15 Aug 2019 17:06:18 GMT
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Administrative Law Overview
Thu, 15 Aug 2019 16:00:00 GMT
This article provides an overview of federal administrative processes as they relate to the regulatory professional.
FDA’s OCE Taps Syapse for Research on RWE
Wed, 14 Aug 2019 20:38:55 GMT
San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to work on using real-world evidence (RWE) to support regulatory decisionmaking.
Osteoporosis: FDA Finalizes Nonclinical Development Guidance
Wed, 14 Aug 2019 20:07:50 GMT
The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on designing long-term nonclinical bone quality studies for drugs and biologics to treat osteoporosis.
FDA Adds New Q&As to Lab Controls Section of CGMP Guidance
Wed, 14 Aug 2019 18:44:00 GMT
The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
Wed, 14 Aug 2019 18:21:09 GMT
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Recon: Cummings, Sanders Question Mylan, Teva & Heritage for Obstructing Price Fixing Probe
Wed, 14 Aug 2019 17:46:40 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
FDA Announces new TRG Rapid Inquiry Program
Wed, 14 Aug 2019 16:00:00 GMT
This article discusses the US Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG) new Rapid Inquiry Program (TRIP).
EC Designates Third Notified Body Under MDR
Wed, 14 Aug 2019 13:35:02 GMT
The European Commission announced on Wednesday that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR).
 
FDA to Drug Manufacturers: Outdated Listings Will be Inactivated
Tue, 13 Aug 2019 20:23:33 GMT
While noting that tens of thousands of drug listing records have not been updated in the past year, the US Food and Drug Administration (FDA) on Tuesday announced that it will begin inactivating drug listings and manufacturing establishment listings in one month.

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