The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.
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their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA.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 Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics Read More
To date, FDA requires all subjects to provide their informed consent before participating in any clinical trial, except when there are life-threatening situations or emergency research conditions.
On November 2018, FDA proposed a new rule that wil…
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).
ASCA Pilot Program goa…
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…
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