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FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators
To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
Do You Qualify for FDA Emergency Use Authorization (EUA) for Coronavirus (COVID-19)?
If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
FDA publishes guidance on conducting clinical trials during COVID-19 Pandemic.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.
How to make Hand-Sanitizer: WHO and FDA recommendations
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FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
The FDA Prepares for the Fourteenth Annual Meeting International Cooperation on Cosmetics Regulation.
The FDA announces on March 3rd that they hold a public meeting regarding the 14th International Cooperation on Cosmetics Regulation (ICCR)- to be held on April 14, 2020.
The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance
FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
FDA RELEASED THE FINAL VERSION OF 6 GUIDANCE’S FOR GENE THERAPY
On 28 January 2020, US FDA released six (6) final guidance documents on Gene Therapy (GT) products.
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 […]
US FDA Expands the Abbreviated 510 (k) Program to Well-known Medical Devices by — Implementing a Safety and Performance Based Pathway
The FDA expands the concept of the Abbreviated 510(k) pathway for certain well understood device types, using the Safety and Performance Based pathway.