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FDA Announces The Discontinuation Of Certain COVID-19-Related Guidance Documents - Operational Impacts and Strategy

April 3, 2023

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023...

United States Coagulation Systems For Measurement Of Viscoelastic Properties Health Care Guidance Documents Expiring With The Public Health Expiration Of The Public Health Emergency Development Of Monoclonal Antibody Products

Source: mondaq.com

The Long (Un)Winding Road: FDA Maps Out How The End Of The Public Health Emergency Will Impact Its COVID-19 Policies - Operational Impacts and Strategy

March 23, 2023

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available...

Party Certification Public Health Emergency Guidance Human Services Regulatory Affairs Development Of Monoclonal Antibody Products Targeting Animal Drug Development

Source: mondaq.com

The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies | Goodwin

March 16, 2023

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be...

Development Of Monoclonal Antibody Products Targeting Party Certification Program Onsite Observation Public Health Emergency Regarding The Qualified Exemption Development Of Abbreviated New Drug Applications During Health Care Professionals Office Of Information

Source: jdsupra.com

FDA Issues More Guidance on Gene and Cell Therapy Products | Morgan Lewis

February 5, 2021

To embed, copy and paste the code into your website or blog: January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. The agency first issued a draft guidance to facilitate the development of individualized antisense oligo...

Morgan Lewis Drug Administration Manufacturing Guidance Manufacturing Practice Considerations Biological Products Material Assessment