1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Gottlieb's 2018 Generic Drug Approval Goal May Be In Doubt

 
• By Derrick Gingery

Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017’s record.

FDA entrance sign 2016

The US FDA must pick up its approval pace significantly if it wants to meet Commissioner Scott Gottlieb's goal of surpassing the 2017 generic drug approval total.

Thanks to a quarter where ANDA clearances plummeted, the agency could see its total full and tentative approvals finish below...

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 US FDA

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
• By Sarah Karlin-Smith

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Agency Leadership

Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 
• By Francesca Bruce

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.