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Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach

 
• By Brenda Sandburg

Patient groups helped with draft guidance on ALS drug development and revision of Alzheimer's draft guidance; agency also issues draft guidance on pediatric seizure, final guidances on DMD and migraine.

Guidance word in red keyboard buttons

The US FDA's five new guidances on development of drugs for neurological diseases showcase several changing aspects of the agency's regulatory approach, from how it works with patients to how it formats documents. 

"FDA recognizes the urgent need for new medical treatments for many serious conditions including neurological disorders such as muscular dystrophies, amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), migraine and epilepsy,"...

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More from Approval Standards

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

More from Pathways & Standards

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.