RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > CBER Director Touts Center's FY2016 Performance

CBER Director Touts Center's FY2016 Performance

Posted 06 January 2017 | By Michael Mezher 

CBER Director Touts Center's FY2016 Performance

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

The report is Marks' first since he rose to head CBER last January, replacing former CBER Director Karen Midthun after her 22-year stint at the agency.

As in previous years, CBER met or exceeded the performance goals for product reviews established by the various User Fee Acts:

CBER Performance Goals
Standard and Priority BLA/NDA Reviews100% on time
Standard and Priority Efficacy Supplements100% on time
MDUFA Decisions100% within 90 day target

Compared with 2015, CBER saw fewer Biologic License Applications (BLAs) with eight BLAs falling within the FY2016 review timeframe as opposed to 13 in FY2015.

CBER Biological License Application (BLA) and Efficacy Supplement Approvals FY2016 (1 October 2015-30 September 2015
ProductApplication TypeIndication
BioThrax (anthrax vaccine)Efficacy SupplementApproval of efficacy supplement to include post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure, when combined with the recommended course of antimicrobial therapy in persons 18 through 65 years of age.
Fluad (adjuvanted seasonal influenza vaccine).BLAFirst adjuvanted seasonal influenza vaccine licensed in the US for the active prevention of seasonal influenza in people 65 years of age and older.
FluLaval Quadrivalent (seasonal influenza vaccine)Efficacy SupplementExtended the age range to include children 6 through 35 months of age for the prevention of seasonal influenza.
Gardasil 9 (human papillomavirus 9-valent vaccineEfficacy SupplementIncludes males 16 through 26 years of age for the prevention of anal cancer and genital warts.
Vaxchora (cholera vaccine live oral)BLAFor the prevention of cholera caused by serogroup O1 in adults 18 through 64 years who travel to cholera-affected areas.
Idelvion (coagulation factor IX (recombinant), albumin fusion protein)BLAFor the treatment and control of bleeding episodes in children and adults with Hemophilia B.
Vonvendi (von Willebrand factor (recombinant))BLAFor the on-demand treatment and control of bleeding episodes in adults 18 years of age and older with von Willebrand disease.
Coagadex (coagulation factor X (human))BLAFirst coagulation factor replacement therapy licensed in the US for patients with hereditary Factor X deficiency.
Adynovate (antihemophilic factor (recombinant))BLAFor use in adults and adolescents aged 12 years and older with Hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes and routine prevention to reduce the frequency of bleeding episodes.
Afstyla (antihemophilic factor (recombinant))BLAIntended for use in adults and children with Hemophilia A (congenital factor VII deficiency) for on-demand treatment and control of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes.
Imlygic (talimogene laherparepvec)BLAFirst oncolytic virus therapy for the treatment of melanoma lesions in the skin and lymph nodes.

Aside from hitting its performance targets for reviews, CBER published a total of 12 guidance documents in FY2016, four of which were published in cooperation with the Center for Drug Evaluation and Research (CDER) or the Center for Devices and Radiological Health (CDRH).

The guidances include four final guidances and six draft guidances, as well as two guidances for immediate implementation intended to reduce the risk of Zika virus transmission.

CBER Guidances FY2016
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Guidance for Industry
Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry
Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry
Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff
FDA's Application of Statutory Factors in Determining When a REMS Is Necessary; Draft Guidance for Industry (CBER/CDER)
Patient Preferences Information-Voluntary Submission, Review in Premarket Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (CBER/CDRH)
Labeling for Biosimilar Products Guidance for Industry (CDER/CBER)
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans  (CBER/CDER)

FY2016 Report from the Director

 

© 2022 Regulatory Affairs Professionals Society.

Tags: CBER, PDUFA, MDUFA, BLA