FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016
By 2020, the Food and Drug Administration (FDA) is planning to change its quality system requirements for medical device manufacturers stipulated in 21 CFR 820 by ISO 13485 :2016. This decision was taken as more and more regulators are looking toward adopting globally harmonized requirements that utilize regulations as well as standards, such as ISO […]
Unique Device Identification (UDI) Systems Expansion in Europe
The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI under the MDR and IVDR in March 2018. It became clear that most markets will have a UDI system within five years . Although it will be […]
FDA New Pilot Program for Orphan Designation Requests
For Rare Disease Day, the FDA lunched a new pilot program to streamline orphan designation requests to make it easier for applicants and reviewers.
FDA-First Agency to Release a Guidance on 3D Printed Products
To keep up with evolving 3D printing technology and to encourage and support innovation in this field, the FDA has released it first technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue. The guidance provides a comprehensive policy framework to manufacturers and a more efficacious pathway to […]
Japan cutting prices of new drugs and off-patent drugs
The Ministry of Health, Labor and Welfare is proposing a considerable cut down in the pricing of both off-patent drugs and expensive innovative treatments, and also set up an annual review of the drug prices.
CFDA New Clinical Data Requirements for Foreign medical devices
CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]
FDA New Guidance on De Novo Classification Process
On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices because they don’t have predicates. And allowing them to be down classified to Class I or Class II devices. A […]
2018 FDA Small-Business Medical Device User Fees
The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees. Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program. The guidance includes separate requirements for US-based and […]
FDA NEWS: Priority Review for Generic on the Way
On June 19, 2017, the US Food and Drug Administration (FDA) released the draft guidance on the priority review of the applications for generics entitled” ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The Pre-Submission Facility Correspondence (PFC) process has been identified by the FDA as part of the performance goals and program enhancements for […]
Nanomaterial Submissions on the Rise
Based on recent FDA analysis, the number of submissions of drugs with nanomaterials has risen considerably over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. This analysis […]
CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers
In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing Multinational Companies to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines. The changes affect the following areas: 1) For imported chemical drugs and […]
Do We Really Need Regulatory Intelligence?
Regulatory intelligence (RI) has emerged as an essential tool for regulatory professionals, but do we really need it? The simple answer is, yes. Using RI will help you to become an effective regulatory professional by helping you to develop the most effective regulatory strategies, while at the same time helping to avoid costly and time-consuming […]