FDA introduces Medical Device User Fee Amendments for Fiscal year 2021
Food and Drug Administration updates lists of Medical Device User Fees for Fiscal year 2021. and increases cost of certain MD submissions.
US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research
The US FDA released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds.
Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations
The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.
FDA holds up UDI enforcement for Class I device
The FDA delays the enforcement of Unique Device Identification (UDI) for Class I medical devices and will come in action from 24 September 2022.
FDA resumes on-site domestic inspection
The United States Food and Drug Administration lifts halt on domestic routine surveillance facility inspections from week of July 20, 2020.
FDA Updates Medical Device Establishments Inspection Processes and Standards
FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments
US FDA releases COVID-19 vaccine guidance
The United States Food and Drug Administration (USFDA) recently released a guidance for COVID-19 vaccine demonstrating at least 50% effectiveness in a placebo-controlled trial.
US FDA releases its first patient focused drug development (PFDD) guidance
The US FDA has released its first patient focused drug development (PFDD) guidance. This guidance is the first methodological guidance( referred as guidance 1) and that will be followed by 3 more guidance’s on this topic.
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
US FDA Facilitates Intellectual Property Rights For Dietary Supplements
The US FDA proposes useful tools to register innovative dietary supplement for New Dietary Ingredient – Master file (NDI-MF).
The FDA Ventilator Requirements for EUA
To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance on the FDA expedite review of new ventilator under the Emergency Use Authorization (EUA) program.
The FDA Introduces the Coronavirus Treatment Acceleration Program (CTAP)
The FDA introduces the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of safe and effective life saving treatments against Coronavirus.