877.717.7997

FlightBlog

Monthly Archives: September 2017

Share on Google+ September 18, 2017

0 Comments

FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

Category : FDA

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework. FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives. This new effort includes areas where FDA’s rules concerning new drugs

View Post

Share on Google+ September 11, 2017

0 Comments

Strengthening EU-US cooperation in medicine inspections

Category : FDA

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with

View Post

Share on Google+ September 4, 2017

0 Comments

FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018

Category : FDA, Medical Device testing

On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018.  The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees are for certain medical

View Post