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This post was drafted by Innovative Science Solutions and Wendell S. Fortson, founder of Fortson Strategies, LLC. Fortson Strategies is a national cancer litigation strategy firm for corporations. Read more
Chemicals are part of everyday life. They are found in common household and workplace products including food, packaging, paint and dyes, cleaning supplies, medicines, among many other categories of products. Read more
This article was authored by Ted Dunkelberger, who provides expertise in litigation strategy and expert recruitment at ISS. Read more
On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention. Read more
The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) convened on November 16th to discuss ciprofloxacin inhalation powder (NDA 209367). Read more
On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical. Read more
The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee. Read more
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th. Read more
On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254). Read more
The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster. Read more
On October 12th, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met to discuss and make recommendations. Read more
The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee met on September 28th to discuss the new drug application (NDA 200896) for Ataluren®. Read more
On September 19th the Oncologic Advisory Committee (ODAC) discussed supplemental new drug application (sNDA 021938/033) for SUTENT® (sunitinib malate) oral capsules, submitted by C.P. Read more
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) convened on September 14th. Read more
On July 26th, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee. Read more
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the afternoon of July 13th to discuss Biologics License Application (BLA) 761074 for Mylan’s biosimilar to Genentech Inc.’s Herceptin (trastuzumab). Read more
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the morning of July 13th to discuss Biologics License Application (BLA) 761028. Read more
On July 12th, 2017 the FDA’s Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 125646 for tisagenlecleucel-T suspension (KYMRIAH™). Read more