The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

FDA Antimicrobial Drugs Advisory Committee Meeting (AMDAC) Recommends Approval of FETROJA (cefiderocol lyophilized powder)
07 February 2020
FDA Antimicrobial Drugs Advisory Committee Meeting (AMDAC) Recommends Approval of FETROJA (cefiderocol lyophilized powder)

On October 16th, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) reviewed. Read more

FDA Panel Recommends Icosapent Ethyl (Vascepa) for Cardiovascular Risk Reduction
18 November 2019
FDA Panel Recommends Icosapent Ethyl (Vascepa) for Cardiovascular Risk Reduction

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 14th to review. Read more

Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)
18 November 2019
Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 13th to discuss the Boehringer Ingelheim Pharmaceuticals. Read more

E-Cigarette Scientific Literature and Experts Can Help Draw the Line Between Nicotine Versus Illicit THC Vaping Products
18 October 2019
E-Cigarette Scientific Literature and Experts Can Help Draw the Line Between Nicotine Versus Illicit THC Vaping Products

This article was co-authored by Steve J. Bannister, PhD, of Hightower Pharmaceutical Services. He has over thirty years of experience applying the fundamentals of physical and analytical chemistry to development of drug-delivery devices. Read more

FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis
22 August 2019
FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis

The Arthritis Advisory Committee (AAC) met on July 25th to review the supplemental New Drug Application. Read more

THE APPLICATION OF GENOMICS IN ASBESTOS AND TALC CASES: DR. LEN VAN ZYL WILL BE SPEAKING AT THE PERRIN NATIONAL ASBESTOS LITIGATION CONFERENCE
14 August 2019
THE APPLICATION OF GENOMICS IN ASBESTOS AND TALC CASES: DR. LEN VAN ZYL WILL BE SPEAKING AT THE PERRIN NATIONAL ASBESTOS LITIGATION CONFERENCE

On September 9-11, Dr. Len van Zyl of ToxicoGenomica will be speaking at Perrin Conferences’ National Asbestos Litigation Conference at the  Fairmont San Francisco Hotel, San Francisco, CA. Read more

FDA Approves Selinexor Despite Panel’s Vote To Delay
06 August 2019
FDA Approves Selinexor Despite Panel’s Vote To Delay

On February 26th, 2019, the Oncologic Drugs Advisory Committee assembled to determine the fate of Karyopharm Therapeutics’ latest drug. Read more

E-Cigarette Expert Witness Teams Will be Key as Litigation Increases: Do E-Cigarettes Cause BOOP, Strokes and Seizures?
31 July 2019
E-Cigarette Expert Witness Teams Will be Key as Litigation Increases: Do E-Cigarettes Cause BOOP, Strokes and Seizures?

E-cigarettes and other reduced risk nicotine products (such as smokeless tobacco, heated tobacco, and tobacco-free nicotine products) have generated enormous interest across a spectrum of stakeholders, including smokers who have reportedly quit smoking using one or more of these new (potentially) reduced risk products. Read more

FDA Advisory Committee in Favor of Mannitol Inhalation Powder
29 July 2019
FDA Advisory Committee in Favor of Mannitol Inhalation Powder

On May 8th, 2019 the Pulmonary-Allergy Drugs Advisory Committee (PADAC) convened to review the new drug application (NDA) Read more

Oncologic Drugs Advisory Committee Supports Pexidartinib but Not Quizartinib
24 July 2019
Oncologic Drugs Advisory Committee Supports Pexidartinib but Not Quizartinib

The Oncologic Drugs Advisory Committee (ODAC) reviewed the new drug application (NDA) #211810. Read more

FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Endorse Esketamine
24 July 2019
FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Endorse Esketamine

On February 12th, 2019, Janssen Pharmaceuticals, Inc. discussed their New Drug Application (NDA) #211243. Read more

Animals Are Not Humans: New Study Identifies Interspecies Differences in PFAS Toxicokinetics
22 July 2019
Animals Are Not Humans: New Study Identifies Interspecies Differences in PFAS Toxicokinetics

In a recently published article, Pizzurro and colleagues report several important interspecies differences in perfluoroalkyl substances (PFAS) toxicokinetics. Read more

Analytical Challenges in PFAS Detection: The Potential for False Positive Results
10 July 2019
Analytical Challenges in PFAS Detection: The Potential for False Positive Results

Per- and polyfluoroalkyl substances (PFAS) are a diverse group of chemical compounds that resist degradation in the environment. Read more

Is Litigation on the Horizon for Sunscreen Manufacturers?
25 June 2019
Is Litigation on the Horizon for Sunscreen Manufacturers?

On May 6, 2019, a study published in the Journal of the American Medical Association reported that several sunscreens used under maximal conditions resulted in plasma concentrations of active ingredients that exceeded the threshold limit established by the U.S. Food and Drug Administration (FDA). Read more

FDA Joint Committee Recommends Approval of Uloric (Febuxostat) Tablets
21 June 2019
FDA Joint Committee Recommends Approval of Uloric (Febuxostat) Tablets

On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees. Read more

FDA Endocrinology and Metabolic Drugs Advisory Committee Split on Approvability of Sotagliflozin Oral Tablet for Diabetes
14 June 2019
FDA Endocrinology and Metabolic Drugs Advisory Committee Split on Approvability of Sotagliflozin Oral Tablet for Diabetes

On January 17th, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed. Read more

Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee
07 June 2019
Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

On June 6th, 2019, the Antimicrobial Drugs Advisory Committee convened to discuss the new drug application. Read more

Welcome To The FDA Blog At ISS!
07 June 2019
Welcome To The FDA Blog At ISS!

Innovative Science Solutions (ISS) is a consulting firm with over two decades of experience in the regulatory industry. Read more