1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Regulation

Format And Content Guidance Aligns US OTC Monograph Order Requests With NDA Process

 
• By Malcolm Spicer

Data and other information draft recommends for OMORs include combined with the common technical document-framed formatting and submitting may be particularly challenging for businesses which market a limited number of OTC drugs, particularly smaller firms.

Before_After
• Source: Shutterstock

The US Food and Drug Administration packed full of instructions a draft guidance on format and content for OTC monograph order requests (OMORs) but still made room to includes requests for more information than firms likely are accustomed to providing for monograph drugs.

“The extent of the data and information details recommended by FDA shows that many OMORs will involve a highly complex...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight 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

Kennedy Suggestion For GRAS Change Grows Rapidly To Planned Date For Proposed Rule

 
• By Malcolm Spicer

Proposed rule to eliminate self-GRAS without submitting regulatory notification planned seven months after HHS Secretary Kennedy Jr. suggested change. Latest HHS regulatory agenda also includes publication of FDA final rule to deem supplements unapproved drugs when co-packaged with drugs.

Former DoJ Antitrust Prosecutor Moves To FTC As Competition Bureau Health Care Division Chief

 
• By Malcolm Spicer

Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.

MAHA Healthy Children Strategy Report Likely To Claim Link Between Acetaminophen And Autism

 
• By Malcolm Spicer

MAHA meeting announcement followed reports that HHS Secretary Robert F. Kennedy Jr. planned in September to release report on potential link to autism from pregnant women’s use of OTC acetaminophen.

Opella Switches Cialis In Norway

 
• By David Ridley

Norway becomes the third European country to approve OTC sales of tadalafil. Cialis reseptfri will “soon be on shelves,” Opella says, with the launched being planned in partnership with Stada Arzneimittel.

More from Policy & Regulation

MAHA Healthy Children Strategy Report Likely To Claim Link Between Acetaminophen And Autism

 
• By Malcolm Spicer

MAHA meeting announcement followed reports that HHS Secretary Robert F. Kennedy Jr. planned in September to release report on potential link to autism from pregnant women’s use of OTC acetaminophen.

Oura Gets Smart Ring Competitors Banned From US, But Faces Ultrahuman Countersuit

 
• By Elizabeth Orr

The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.

Opella Switches Cialis In Norway

 
• By David Ridley

Norway becomes the third European country to approve OTC sales of tadalafil. Cialis reseptfri will “soon be on shelves,” Opella says, with the launched being planned in partnership with Stada Arzneimittel.