1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

FDA finalises guide for ANDA content

Guidance intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to the US Food and Drug Administration (FDA), identifying the information “that an applicant should include to ensure that a complete, high-quality application is submitted to FDA”, has been finalised by the US agency.

Guidance intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to the US Food and Drug Administration (FDA), identifying the information “that an applicant should include to ensure that a complete, high-quality application is submitted to FDA”, has been finalised by the US agency.

A follow-up to draft guidance issued by the FDA more than four years ago (Generics bulletin, 20 June 2014, page...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Regulation

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

More from Policy & Regulation

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.