Major Upgrades In Store For The US FDA's Inactive Ingredients Database

A US FDA official has announced that major revisions are underway to address problems with the agency’s Inactive Ingredient Database. These include replacing potency limits with a maximum daily exposure limit and adopting standard terminology for routes of administration. In its current form, the IID has been a source of confusion for industry.

Collage assortment of pills, capsules and tablets - Image

The pharmaceutical industry will soon see major improvements in the FDA’s Inactive Ingredient Database, according to a US FDA official.

Later this year, the FDA will begin using a standardized terminology to denote the route of administration and the dosage...

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

More from Manufacturing

EU’s Draft GMP Guideline Signals Major Cultural Shift In Pharma Quality Compliance

 
• By 

While the EU's draft good manufacturing practice guideline on pharmaceutical quality systems reflects modern quality management principles, it also presents significant operational and resource challenges for drug companies.

EU GMP Changes Target Supply Chain Risks And Product Shortages

 
• By 

The European Commission’s proposed update of its good manufacturing practice guideline on pharmaceutical quality system calls for smarter risk management to safeguard drug quality and supply.

Ultra-Rare Cancers Partnership Launches With Two Pilot Indications, Seeks Industry Help

 
• By 

A molecular target and platform technology for each indication will be selected at a November public meeting, while sustainable manufacturing issues remain ongoing.

EU Critical Medicines Act: Parliament Clarifies ‘Significant Proportion’ Rule

 

The European Parliament has suggested clear rules on the proportion of medicinal product manufacturing that must take place in the EU, EEA, or Switzerland for drugmakers to be favored under the Critical Medicines Act, which aims to drive investment in Europe.

More from Compliance

US FDA DTC Ad Crackdown Could Force Shift In Spending, Regulatory Focus

 

Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.

E-Pharmacies In India: Mind The Data Privacy Gap, Regulatory Deficit

 

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.

US FDA Reveals DTC Enforcement Approach In Letter For AstraZeneca’s FluMist Ad

 

FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.