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Policy

Industry Says EMA’s Strict New Conflict Of Interest Rules Could Limit Access To Experts

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

EMA’s Conflict Of Interest Rules Must Not Limit Access To Experts And Risk Innovation, Warns Industry

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

Using Synthetic Dye For Cherry-Pink Shade In US Ends In 2 Years For Supplements, 3 For Oral Drugs

Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.

UK Pathology Champions Bigger Role For Biomedical Scientists In Evolving NHS

Greater reliance on point-of-care testing ticks the patient-centricity box of UK’s proposed elective care reform. But quality oversight from pathology professionals is vital to ensure that the safety and reliability boxes are also ticked, says the Institute of Biomedical Science.

FTC Proposed Rule Change Targeting Direct Sellers Gets Direct Challenge From Incoming GOP Majority

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

Game-Changing EU-Level HTA Regs Must Allow For Lessons To Be Learned

EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.

EU Pharma Reform: Industry Pushes For Early Roll-Out Of Electronic Product Information

Pharmaceutical industry says the transition from paper to electronic product information, as part of EU pharmaceutical reforms, should not be held back by member states' readiness.

Medtech Radar 2025: EU’s MDR Woes – Paying The Price For ‘Fixing It When It Ain’t Even Broke’

ZS principal Brian Chapman tells In Vivo what is troubling the global medtech industry at the turn of 2025, and takes the opportunity to chide the EU for its persistent fixation on taking on the “problem that did not need to be solved.”

Revenue Drain Among Challenges For ACNU OTC Marketers From Simultaneous Rx Availability

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.