1. Pink Sheet
  2. >>Geography
  3. >>Europe

FDA Jump Starts Broader Records Access Under Food Safety Reform

 
• By Malcolm Spicer

The agency dispenses with notice and comment before imposing an IFR because the authority for expanded access to food product firms’ records was effective when FSMA became law in January 2011. FDA also publishes a draft guidance on FSMA-imposed records regulations.

FDA will impose an interim final rule March 1 – without prior notice and comment – detailing its expanded access to food and supplement manufacturers’ records as granted by the Food Safety Modernization Act.

The agency says it dispensed with notice and comment before imposing the IFR because its expanded authority went...

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 Europe

UK Budget: Little Mention Of Pharma, But Some Support For Innovators

 
• By Eliza Slawther

The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.

Who Does What? EU RADIAL Study Exposes Oversight Challenges In Decentralized Trials

 
• By Vibha Sharma

Decentralizing clinical research demands rethinking accountability and logistics to prevent gaps that could compromise safety and trial integrity.

European Commission Dismisses Calls For Pause On Waste Water Directive

 
• By Anabel Costa-Ferreira

The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”

EU HTA Regulation Brings Alignment – But National ‘Recipes’ Still Rule Reimbursement

 
• By Eliza Slawther

While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.

More from Geography

Trump’s Semaglutide Most Favored Nation Price Will ‘Supersede’ Medicare MFP

 
• By Cathy Kelly

The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.

AI Boosts Parkinson’s Disease Cell Therapy Development

 
• By Bridget Silverman

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

PhRMA Urges Japan To Maintain Drug Prices Amid MFN Concerns

 
• By Lisa Takagi

While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.