SAC Tracker

Information about US FDA Scientific Advisory Committee (SAC) meetings

[SAC Tracker @FDAadcomm]

Upcoming US #FDA drug and biologic advisory committee meetings 📅 https://t.co/ZkDd3FN5bo

[SAC Tracker @FDAadcomm]

The CRDAC will discuss sNDA on September 13, 2023, for ONPATTRO lipid complex injection, submitted by @Alnylam Pharmaceuticals for the proposed treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults.

[SAC Tracker @FDAadcomm]

The Endocrinologic and Metabolic Drugs Advisory Committee votes in favor of Palovarotene capsules, submitted by Ipsen Biopharmaceuticals for the prevention of Heterotopic ossification in adults and children with FOP.

[SAC Tracker @FDAadcomm]

On Wednesday, June 28, 2023, the Endocrinologic Drugs Advisory Committee will discuss new drug application (NDA-215559), for Palovarotene capsules, submitted by Ipsen Biopharmaceuticals for the prevention of heterotopic ossification in adults and children with FOP.

[SAC Tracker @FDAadcomm]

The EMDAC votes in favor of Palovarotene capsules, submitted by Ipsen Biopharmaceuticals for the prevention of Heterotopic ossification in adults and children with FOP.

[SAC Tracker @FDAadcomm]

On Wednesday, June 28, 2023, the Endocrinologic Drugs Advisory Committee will discuss new drug application (NDA-215559), for Palovarotene capsules, submitted by Ipsen Biopharmaceuticals for the prevention of heterotopic ossification in adults and children with FOP.

[SAC Tracker @FDAadcomm]

The PCNS advisory committee votes unanimously (6-Yes; 0- No;0-Abstain) for LEQEMBI (lecanemab), submitted by Eisai, Inc, for the treatment of Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of disease.

[SAC Tracker @FDAadcomm]

On Friday, June 9th, 2023, the PCNS advisory committee will discuss sBLA (761269/s-001), for Lecanemab intravenous infusion, submitted by @Eisai, for the treatment of Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of disease.

[SAC Tracker @FDAadcomm]

On Wednesday, June 28, 2023, the Endocrinologic Drugs Advisory Committee will discuss new drug application (NDA-215559), for Palovarotene capsules, submitted by Ipsen Biopharmaceuticals for the prevention of heterotopic ossification in adults and children with FOP.

[SAC Tracker @FDAadcomm]

The VRBPAC unanimously recommends on the periodic update of the current vaccine composition to a monovalent XBB-lineage for the 2023-2024 vaccination campaign.

[SAC Tracker @FDAadcomm]

The VRBPAC on June 15th 2023, will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

[SAC Tracker @FDAadcomm]

The VRBPAC on June 15th 2023, will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

[SAC Tracker @FDAadcomm]

The AMDAC votes unanimously in support of Nirsevimab submitted by @AstraZeneca for the prevention of RSV LRTD in neonates and infants born during or entering their first RSV season and in Children up to 24 months of age.

[SAC Tracker @FDAadcomm]

On June 8th 2023, the AMDAC will discuss a BLA for Nirsevimab, submitted by @AstraZeneca for the prevention of RSV LRTD in neonates and infants born during or entering their first RSV season and in children up to 24 months of age.

[SAC Tracker @FDAadcomm]

On Friday, June 9th, 2023, the PCNS advisory committee will discuss sBLA (761269/s-001), for Lecanemab intravenous infusion, submitted by @Eisai, for the treatment of Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of disease.

[SAC Tracker @FDAadcomm]

On June 8th 2023, the AMDAC will discuss a BLA for Nirsevimab, submitted by @AstraZeneca for the prevention of RSV LRTD in neonates and infants born during or entering their first RSV season and in children up to 24 months of age.

[SAC Tracker @FDAadcomm]

The GIDAC panel voted 15-to-1 (15- No; 1- Yes; 0- Abstain) against the approval of OCA obeticholic acid (OCA) for treating NASH patients with fibrosis

[SAC Tracker @FDAadcomm]

On Friday, May 18, 2023, the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting will discuss NDA- 212833 for Obeticholic acid (OCA) 25 mg oral tablets, submitted by @InterceptPharma Inc., for the treatment of pre-cirrhotic liver fibrosis due to NASH.

[SAC Tracker @FDAadcomm]

The VRBPAC panel voted unanimously (14-0) on the ABRYSVO's effectiveness, and (10 -14) voted on the safety of ABRYSVO vaccine n infants from birth through 6 months of age by active immunization of pregnant individuals.

[SAC Tracker @FDAadcomm]

On May 18, 2023, the VRBPAC will review BLA of ABRYSVO vaccine, submitted by @pfizer, for the prevention of LRTD and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.

[SAC Tracker @FDAadcomm]

On Friday, May 18, 2023, the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting will discuss NDA- 212833 for Obeticholic acid (OCA) 25 mg oral tablets, submitted by @InterceptPharma Inc., for the treatment of pre-cirrhotic liver fibrosis due to NASH.

[SAC Tracker @FDAadcomm]

The CTGTAC votes 8–6 (8 Yes; 6 No; 0 Abstain) in favor of SRP-9001 stating the considerations of benefit and risk, taking into account the existing uncertainties, at week 12 as a surrogate end point.

[SAC Tracker @FDAadcomm]

The CTGTAC on Friday May 12, 2023 will review Biologic license application (BLA 125781) submitted by @Sarepta Therapeutics, Inc. for delandistrogene moxeparvovec for the treatment of (DMD) with a confirmed mutation in the DMD gene.

[SAC Tracker @FDAadcomm]

On May 18, 2023, the VRBPAC will review BLA of ABRYSVO vaccine, submitted by @pfizer, for the prevention of LRTD and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.

[SAC Tracker @FDAadcomm]

The CTGTAC on Friday May 12, 2023 will review Biologic license application (BLA 125781) submitted by @Sarepta Therapeutics, Inc. for delandistrogene moxeparvovec for the treatment of (DMD) with a confirmed mutation in the DMD gene.

[SAC Tracker @FDAadcomm]

The PADAC majority votes in favor of epinephrine spray (17- Yes; 5- No; 0- Abstain) submitted by ARS Pharmaceuticals Inc., for the emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children ≥ 30 kgs.

[SAC Tracker @FDAadcomm]

On 11th May 2023, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) will discuss NDA 214697, for epinephrine nasal spray, submitted by ARS Pharmaceuticals Inc., for the emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children ≥ 30 kgs.

[SAC Tracker @FDAadcomm]

On 11th May 2023, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) will discuss NDA 214697, for epinephrine nasal spray, submitted by ARS Pharmaceuticals Inc., for the emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children ≥ 30 kgs.

[SAC Tracker @FDAadcomm]

The Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) votes unanimously (17- Yes; 0- No; 0- Abstentions) stating that the benefits of OPILL contraceptive available for OTC use outweighs the risks.

[SAC Tracker @FDAadcomm]

On 9th and 10th May 2023, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will discuss sNDA for OPILL (norgestrel) tablet, submitted by Laboratoire HRA Pharma for nonprescription use to prevent Pregnancy

[SAC Tracker @FDAadcomm]

On 9th and 10th May 2023, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will discuss sNDA for OPILL (norgestrel) tablet, submitted by Laboratoire HRA Pharma for nonprescription use to prevent Pregnancy