FDA rule changes are causing delays in product approval, leading to the process exceeding Congressional mandated timeframes.

The entities involved

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• Company →

  Direct Mail Division of FSSI

  • A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Mon 13:17
  • A partnership with BARDA has accelerated the development of SCY-247 for the company.Mon 13:17

Related events

• Humane World for Animals petitioned the FDA and lobbied Congress regarding drug approval regulations.Sep 22
• Unregulated products are bypassing official government approval processes.Aug 12
• Litigation regarding FDA approval process.Sep 2
• Policymakers are considering ways to influence the drug market, including potential changes to patent rights and the FDA approval process.Aug 27
• The FDA is accused of failing to enforce safety regulations and operating under current rules without in-person oversight.Aug 27