1. Scrip
  2. >>Therapy Areas
  3. >>Anti-infective

India Tweaks Audio-Visual Norms For Trials

 
• By Anju Ghangurde

India has tweaked requirements around audio-visual recording of the informed consent process for clinical trials, relaxing the rules a little for HIV and leprosy drugs, but industry claims that the revised norms lack clarity on certain key aspects.

India has tweaked requirements around audio-visual recording of the informed consent process for clinical trials, relaxing the rules a little for HIV and leprosy drugs, but industry claims that the revised norms lack clarity on certain key aspects.

Details in a government notification mandate that audio-video recording of the informed consent process in case of "vulnerable" subjects in clinical trials of new chemical entities (NCEs) or new molecular...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Anti-infective

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Gilead Ready To Go After Hepatitis D Again

 
• By Joseph Haas

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By Joseph Haas

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Chinese Vaccine Makers Turn To Emerging Markets

 
• By Dexter Jie Yan

Chinese producers of novel vaccines are increasingly pivoting to developing markets overseas in the face of a collapse in their domestic sales.

More from Therapy Areas

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By Kevin Grogan

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.