This committee was formerly the Anti-Infectives Drug Advisory committee. In February of 2015, the name was changed and the Antiviral Advisory Committee was dissolved and responsibilities for antivirals was absorbed into this committee as well.
The broader heading for this committee allows FDA flexibility for an array of product types. From issues of antibiotic resistance to new therapies for resistant pathogens, this committee hopes to be busy as the medical community tries to respond to the worldwide crisis in antibiotic resistance.
In early 2015 as this Committee was still preparing to take on its new name, a treatment for fungal infections, often associated with cancer chemotherapy or other forms of immunosuppression, was supported.
The FDA's now defunct Antiviral Drugs Advisory Committee was well known for its review of investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) related illnesses, and other viral, fungal, and mycobacterial infections.
ECG's experience with the Antiviral Committee dates back to the early days of the HIV epidemic. ECG supported two of the first three protease inhibitors ever approved for HIV as well as many of the therapies that have followed. ECG has led 20 client projects preparing for AVDAC meetings, virtually all of these projects for HIV or Hepatitis B or Hepatitis C indications. In 2011 the Committee only met twice for product approvals, with ECG supporting one of the two sponsors. In 2012, the AVDAC only considered two product approvals as well, and ECG supported both. In 2013, there was a massive shift in Hepatitis C treatment with the approvals of new generation treatments and again, ECG supported both.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming AMDAC meeting.