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Set Alert for COVID-19

Perrigo Steers Through Transportation Obstacles, Soaring Shipping Costs From COVID-19

Perrigo largely has resolved distribution problems, but shipping freight costs still are much higher than pre-pandemic and it must divest a wound-care brand before US regulators sign off on acquisition of HRA Pharma, says CEO Murray Kessler during J.P. Morgan conference.

Coronavirus COVID-19 M & A

Califf Clears First Senate Hurdle, But FDA Decision On Abortion Pill May Complicate Final Confirmation

Republican opposition to Califf over agency’s recent move to relax its Mifeprex restrictions is ominous since, in order be confirmed as commissioner, he’ll need enough GOP votes to make up for Democratic opposition over his opioid track record and connections to pharma industry.

FDA Leadership

France ‘Not Receptive’ To Self-Care, But Wellness And E-Commerce Trends Are Driving Change

Regulatory barriers, government conservativism and a generous reimbursement system have all held back the development of France's self-care market. However, executive director of the French self-care industry association, Luc Besançon, thinks that the growing trends for prevention and e-commerce will change this in the future. 

France Health

Omicron Forces US FDA To Again Pause ‘Certain Inspectional Activities’

COVID-19 pandemic’s latest variant has pushed FDA to pump brakes again on performing on-site surveillance inspections through at least 19 January. Meanwhile, associate commissioner says Remote Regulatory Assessments “are here to stay.”

Coronavirus COVID-19 FDA

Supplement GMP Warnings Followed After US FDA Restarted Facility Inspections

GMP warnings to firms making supplement firms marketed in US have been rare since FDA temporarily suspended on-site inspections with onset of COVID-19 pandemic. But GMP problems surfaced after agency resumed inspections last July.

Dietary Supplements FDA

CEOs Urge ‘Civility’ In Supply Chain Dealings; ‘We’re Going To Come Out Of This At Some Point’

Today’s global supply chain is trying, but there’s opportunity amid the frustrations for companies to strengthen vendor and customer relations that pay off down the road, according to contract manufacturing and consumer product CEOs speaking to HBW Insight.

International Supply Chain

FDA Outlines Phased Approach To Return Products To Full Compliance After Emergency Use Ends

The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.

Coronavirus COVID-19 FDA

Potential Consumer Demand For Disposable Masks Poses Industry Promise And Marketplace Peril

Consumer demand for masks likely won’t slow following the pandemic, says DemeTECH VP Luis Arguello Jr. The maker of surgical and N95 masks as well as other personal protection and medical procedure equipment has continued manufacturing masks despite supply chain disruptions and competition from lower-cost imports that stymied some domestic firms.

Coronavirus COVID-19 Enforcement
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