viernes, 6 de abril de 2018

Two FDA Public Workshops: Generic Drug Regulatory Science Initiatives and Medical Gas Regulation

1. FY 2018 Generic Drug Regulatory Science Initiatives Public Workshop 

The FDA is hosting the FY 2018 Generic Drug Research Public Workshop to give an overview of the status of regulatory science initiatives for generic drugs. We want your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information obtained from the public workshop into account in developing our fiscal year 2019 regulatory science initiatives. Electronic or written comments will be accepted at any time until the Federal Register Notice docket closes on June 25, 2018.

For more information about this meeting please visit our website.  

2. Medical Gas Regulation; Public Workshop 

The FDA will hold a public workshop on medical gas regulation, entitled “Medical Gas Regulation: Workshop III” on May 11, 2018.  There is no cost and participants may attend in person or via live webcast

The purpose of the public workshop is to hear stakeholder views on areas FDA should consider for potential revisions to Federal drug regulation with respect to medical gases. During the workshop, FDA panels will discuss issues related to medical gas regulation, including topics previously raised at past public workshops. Potential areas for medical gas regulation change that stakeholders may wish to discuss include:  
  • Labeling
  • Current good manufacturing practice
  • Registration and listing
  • Post-market reporting of adverse drug experiences
  • The designated medical gas certification process
  • Oxygen container filling by EMS providers and health care facilities
  • Other topics of interest to stakeholders or FDA

The FDA has issued a Federal Register Notice and opened a public docket for written comments. Please see the Federal Register notice for more information about attending the public workshop or submitting comments to the public docket (due by August 9, 2018).  

For more information about this and previous workshops, please visit the Medical Gas Regulation Public Workshops page  or e-mail

Thank you for your interest in this and other topics related to the FDA.

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