Inside Regulatory Affairs

This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.

In this installment of HBW Insight’s “Inside Regulatory Affairs” series, we hear from Sharee Crumbey and Monica Sharda, regulatory affairs specialists at The Honest Company, about the mounting challenges and rewards of the job.

This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to CHPA’s Mike Bailey, senior vice president of regulatory and scientific affairs; and regulatory and scientific affairs VPs Marcia Howard and Jay Sirois.

HBW Insight presents a new series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries. In this first installment, we speak to AESGP's Christelle Anquez-Traxler and Oliver Hartmann, senior regulatory science & strategy lead, and regulatory & legal affairs director respectively. 

FDA says plan forwarded for review by Department of Health and Human Services to start “formal external review process.” After “several critical steps” which would follow HHS sign-off, FDA expects to implement unified Human Food Program during 2024.

Companies preparing for adverse event reporting and recordkeeping deadlines on 29 December under new cosmetics regulations should ensure they have systems in place for netting complaints across media, triaging reports, and making speedy weight-of-evidence determinations, said SafetyCall International’s Rick Kingston at IBA’s recent FDA regulatory workshop.

Larger box “would accommodate all five steps on the single back panel,” says Emergent executive Manish Vyas. But FDA says proposed DFl for OTC Narcan nasal spray “has not yet been officially submitted or reviewed.”

All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during  meeting.

More than 1,000 comments were submitted by professional and civic organizations, trade groups and consumers FDA proposed rule on allowing OTC sales of hearing aids intended for consumers with mild to moderate hearing loss.

HBW Insight reports on a packed agenda at the AESGP's Regulatory Conference on 25 November. Panels discuss the implications of raft of legislative changes for the European self-care industry, including the incoming EU Pharmaceutical Strategy, the new Medical Devices Regulations, and the inter-related European Green Deal, Farm to Fork and Chemicals Strategies. The conference also saw the launch of the GSCF's Charter for Environmentally Sustainable Self-Care.

Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.

Emer Cooke seems set to take over as head of the European Medicines Agency – one of the world's most powerful regulatory bodies – before the end of the year. We report on the reaction of a range of pharmaceutical sector stakeholders to her nomination.