1. Pink Sheet
  2. >>Legislation

Not Quite FDARA Add-Ons: Right-To-Try, Patient Experience, Opioid Measures Also Clear US Senate

 
• By Sue Sutter

Senate passage of the FDA user fee package without amendments was enabled by unanimous consent votes on controversial right-to-try legislation that is toned down from its initial version, as well as two other bills.

The US Senate's vote on the House's version of the FDA Reauthorization Act (FDARA) without any amendments was preceded – and enabled – by the quick and easy passage of three pharmaceutical-related bills, including controversial right-to-try legislation that was substantially toned down from its original version.

Had the Senate approved the three bills as amendments to the House's version of FDARA, the amended user fee reauthorization package would have had to go back to the House...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

More from Pink Sheet

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

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.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.