FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics
OVERVIEW Companies developing novel drugs or biologic products for rare diseases or other life-threatening diseases can now plan clinical studies for Investigational New Drugs (INDs) to establish their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA. GUIDANCE: ‘Providing Evidence of Effectiveness of Human Drug […]
FDA Waiving the Informed Consent for Minimal Risk Clinical Studies
On November 2018, FDA proposed a new rule that will allow investigators to request a waiver of the informed consent from the IRB for minimal risk clinical studies.
FDA New Pilot Program for Medical Device Conformity Assessment Accreditation
By September 20120, the US Food and Drug Administration (FDA) is planning to lanch its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).
New FDA Pilot Program for 510(k) “Quik” Review
FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devic…
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 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 […]