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Detention & Hearing
… /industry/fda-import-process/detention-hearing … Overview When products in your shipment violate or … This notice is considered the Notice of Detention and Hearing. Why was my product detained? What can I do if my … I notified that my product has been detained? What is a “hearing”? What is Testimony? What is the “respond by” date on …
Regulations and Federal Register Documents (PDUFA)
… Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments; November 2-3, 2010 (PDF - …
FY 2016 Regulatory Science Initiatives Part 15 Public Meeting
… attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by … GDUFA Meeting Final Transcript May 20, 2016 Part 15 Public Hearing GDUFA 2012 Reg. Sci. Initiatives … Center for Drug …
International Mail Facilities
… be Destroyed .” For more information on the Detention and Hearing process visit the Detention & Hearing web page . What happens after the intended recipient …
Improving the Quality of ANDA Submissions
… and supplements. Specifically, FDA is interested in hearing about difficulties sponsors are having developing and …
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
… Meeting Report September 28, 2018 Chemotherapy-Induced Hearing Loss EL-PFDD Meeting Host: Children’s Cause for … Listening Session Summary April 28, 2021 Sensorineural Hearing Loss (SNHL) EL-PFDD Meeting Host: Hearing Loss Association of America Meeting Report May 25, …
108th Congress Report - House Of Representatives
… after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance …
GDUFA I
… of the generic drug user fee program. GDUFA Public Hearing on Policy Development Generic Drug User Fee (GDUF) …
GDUFA Federal Register Notices
… Guidance) Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments Guidance …
Embracing the Role of Patients in Treating Rare Diseases
… candidates who have experience with a rare disease. Hearing those tragic and heart-wrenching stories provided me …
Actions & Enforcement
… Protection (CBP) to demand redelivery. Detention & Hearing If the product appears to be in violation, the …
Import Refusals
… not provide a response to the FDA Notice of Detention and Hearing within the specified ten business days and an …
Color Additives History
Current Regulations: 21CFR 814 Subpart H: Humanitarian Use Devices
… after providing notice and an opportunity for an informal hearing. [61 FR 33244, June 26, 1996, as amended at 63 FR … provide the applicant with notice and an opportunity for a hearing as required for PMA's under Sec. 814.46(c) and (d), …
Panel 2 - Presentations by Academic Research Groups, Prescription Drug User Fee Act Public Meeting November 14, 2005
… and I appreciate the opportunity to participate in this hearing. As you just heard, I am director of the Tufts Center … than others. [Slide.] Now, more germane to this particular hearing, we also asked questions to both industry and the …
Examination & Sample Collection
… violation, a Notice of FDA Action (Notice of Detention and Hearing) will be issued. The product will remain on hold …
Import Alerts
… to refusal into the United States. Visit the Detention and Hearing page for more information on this process. Contact …
Summary of the Medical Device User Fee and Modernization Act of 2002
… accreditation (following an opportunity for an informal hearing) if we find an accredited person is "substantially … our accreditation pending an opportunity for an informal hearing. Id. Not all establishments are eligible for …
Open Public Comment Prescription Drug User Fee Act Public Meeting November 14, 2005
Generic Drug User Fee Amendments
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250
… after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance …