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Preparing For The Return Of US FDA Inspections

 
• By Bowman Cox

Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.

Businessman drawing on virtual screen "Inspection".

As waves of fear gripped the world due to the COVID-19 pandemic, travel restrictions in 2020 swiftly brought profound changes to the US Food and Drug Administration’s enforcement program. The changes continue today and will reverberate in the years ahead.

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More from International

Stada Expands Oilatum Range To Meet Saudi Arabia’s Skin-Care Needs

 
• By David Ridley

Stada launches nine new Oilatum products in Saudi Arabia including “rich moisturising creams for intense hydration, gentle body washes for daily cleansing, and baby-specific products like soothing bath bubbles and head-to-toe wash.”

Bayer And GSCF Paper Outlines ‘Practical Actions’ For Scaling Self-Care Globally

 
• By David Ridley

Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."

UK Honors PAGB’s Riddalls And ISF’s Webber For Self-Care Service

 
• By David Ridley

PAGB CEO Michelle Riddalls and ISF president emeritus David Webber have been awarded OBEs for their services to consumer health and self-care.

People On The Move: Appointments At GSCF, MENAP-SCI, Clasado

 
• By Tom Gallen

A round-up of the latest consumer health industry appointments: GSCF names next director general, MENAP-SCI elects chairman; Clasado hires BD director.

More from Geography

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By David Ridley

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.