1. Generics Bulletin
  2. >>Products
  3. >>Generics

ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

 
• By Derrick Gingery

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.

FDA entrance sign 2016

Pre-submission meetings with the US FDA are popular among complex generic sponsors, but there are questions about how best to make them part of the product development process, since it appears even companies are having trouble fitting them into their schedules.

"A current challenge is how industry will integrate product development and pre-submission meetings into a product development timeline," according the...

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 Generics

IGBA Asks G7 To Consider Access Issues

 
• By Dave Wallace

The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.

Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 
• By Anju Ghangurde

Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

 
• By Dean Rudge

In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.

Lupin Looks To Expand In China With Respiratory Alliance

 
• By Dave Wallace

Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.

More from Products

Outlook Launches Ophthalmic Bevacizumab In Germany And The UK

 
• By Urtė Fultinavičiūtė

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
• By Dave Wallace

As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By Dean Rudge

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.