SAC Meeting Calendar

The SAC Tracker Background Analysis is available in this calendar until 10 days after the meeting is held.

 
 

Newest Meeting Announcements

Newest Background Analyses

Featured
Meeting Announcement FDA, ODAC jessica adams Comment
Meeting Announcement FDA, ODAC jessica adams Comment
JUN 21-22 ODAC
Meeting Announcement FDA, ODAC jessica adams Comment
Meeting Announcement FDA, ODAC jessica adams Comment

Potential pediatric development plans/written requests for: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company; and (5) Olaratumab, presentation by Eli Lilly and Company. 

Meeting Announcement FDA, ODAC jessica adams Comment
Meeting Announcement FDA, ODAC jessica adams Comment
Meeting Announcement FDA, EMDAC jessica adams Comment
Meeting Announcement FDA, EMDAC jessica adams Comment
JUN 20 EMDAC
Meeting Announcement FDA, EMDAC jessica adams Comment
Meeting Announcement FDA, EMDAC jessica adams Comment

Novo Nordisk VICTOZA (liraglutide) for the proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors

Meeting Announcement FDA, EMDAC jessica adams Comment
Meeting Announcement FDA, EMDAC jessica adams Comment
Featured
Background Analysis FDA, SBFDA jessica adams Comment
Background Analysis FDA, SBFDA jessica adams Comment
JUN 26 SBFDA
Background Analysis FDA, SBFDA jessica adams Comment
Background Analysis FDA, SBFDA jessica adams Comment

1) FDA's biotechnology activities related to plant-derived food and animals

2) Report from the National Antibiotic Resistance Monitoring System Review Subcommittee

Background Analysis FDA, SBFDA jessica adams Comment
Background Analysis FDA, SBFDA jessica adams Comment
Background Analysis FDA, ODAC jessica adams Comment
Background Analysis FDA, ODAC jessica adams Comment
JUL 12 ODAC
Background Analysis FDA, ODAC jessica adams Comment
Background Analysis FDA, ODAC jessica adams Comment

Tisagenlecleucel-T suspension by Novartis Pharmaceuticals Corp. for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)

Background Analysis FDA, ODAC jessica adams Comment
Background Analysis FDA, ODAC jessica adams Comment

Newest Briefing Summaries

Newest Results Wires

Featured
Briefing Summary FDA, SBFDA jessica adams Comment
Briefing Summary FDA, SBFDA jessica adams Comment
JUN 26 SBFDA
Briefing Summary FDA, SBFDA jessica adams Comment
Briefing Summary FDA, SBFDA jessica adams Comment

1) FDA's biotechnology activities related to plant-derived food and animals

2) Report from the National Antibiotic Resistance Monitoring System Review Subcommittee

Briefing Summary FDA, SBFDA jessica adams Comment
Briefing Summary FDA, SBFDA jessica adams Comment
Briefing Summary FDA, ODAC jessica adams Comment
Briefing Summary FDA, ODAC jessica adams Comment
JUN 21-22 ODAC
Briefing Summary FDA, ODAC jessica adams Comment
Briefing Summary FDA, ODAC jessica adams Comment

Potential pediatric development plans/written requests for: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company; and (5) Olaratumab, presentation by Eli Lilly and Company. 

Briefing Summary FDA, ODAC jessica adams Comment
Briefing Summary FDA, ODAC jessica adams Comment
Featured
Results Wire FDA, SBFDA jessica adams Comment
Results Wire FDA, SBFDA jessica adams Comment
JUN 26 SBFDA
Results Wire FDA, SBFDA jessica adams Comment
Results Wire FDA, SBFDA jessica adams Comment

Commissioner and Chief Scientist Updates / FDA's biotechnology activities related to plant-derived food and animals / Report from the National Antibiotic Resistance Monitoring System Review Subcommittee

Results Wire FDA, SBFDA jessica adams Comment
Results Wire FDA, SBFDA jessica adams Comment
Results Wire FDA, ODAC jessica adams Comment
Results Wire FDA, ODAC jessica adams Comment
JUN 21-22 ODAC
Results Wire FDA, ODAC jessica adams Comment
Results Wire FDA, ODAC jessica adams Comment

Potential pediatric development plans/written requests for: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company; and (5) Olaratumab, presentation by Eli Lilly and Company. 

Results Wire FDA, ODAC jessica adams Comment
Results Wire FDA, ODAC jessica adams Comment

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