Name: Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s by Citeline
Duration: 14 min
Description: This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form.

The UK’s consumer healthcare industry association, PAGB is publishing a series of blog posts for Self-Care Week – an annual awareness campaign in the UK organized by the Self Care Forum, held this year from 17-23 November. In this special episode of HBW Insight’s Over the Counter podcast, we catch up with the association’s CEO Michelle Riddalls, to talk about what the association is doing to promote Rx-to-OTC switch in the UK. According to Riddalls, two-thirds of PAGB members see reclassification as a key pillar of growth in the next 10-15 years. The UK government has also announced it wants to see switch applications for 16 medical conditions and categories, including sleep, pain, allergy and women's intimate health. Through initiatives like the Reclassification Alliance, PAGB is working hard to unlock this significant growth opportunity for the UK consumer health industry, Riddalls explains. 

Timestamps
3:00 – Introductions
4:00 – PAGB and Self-Care Week 
5:30 – How PAGB is helping to enable Rx-to-OTC switch
8:00 – The benefits of switching for the consumer health industry
11:00 – Riddalls’ switch experience
15:00 – UK government’s switch agenda
18:00 – Switch barriers
22:00 – Thinking outside the box

Guest Bio
Michelle Riddalls OBE is chief executive officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.
Prior to joining PAGB, Riddalls was director of regulatory affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch.
Michelle has been recognized across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Over The Counter Special: Unlocking Switch-Driven Growth, With PAGB’s Michelle Riddalls

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interviews with leaders at brain-computer interface developers Synchron and INBRAIN about funding, clinical trials and partnerships. Brian Bossetta discusses Oura’s goal to secure US FDA clearance for a blood pressure feature for its smart ring. Elizabeth Orr highlights an FDA expert panel considering regulation of generative AI tools for mental health and Shubham Singh shines a light on Choice’s efforts to develop a new form of contraceptive for women.

Digital Health Roundup: BCIs Surge Ahead, Oura Eyes BP Clearance, AI Faces New Scrutiny

The UK’s consumer healthcare industry association, PAGB is publishing a series of blog posts for Self-Care Week – an annual awareness campaign in the UK organized by the Self Care Forum, held this year from 17-23 November. In this second part of a special episode of HBW Insight’s Over the Counter podcast, we catch up with the association’s CEO Michelle Riddalls, to talk about what the association is doing to promote digital health. As part of the UK government’s plans for reforming the country’s National Health Service, PAGB is asking for the widely used UK NHS app to not only advise people on how to self-care but also to take users to OTC brand websites that can help them to self-manage their conditions appropriately. We also discuss the advantage of having digital apps and self-care information generally linked to trusted umbrella brands. 

Timestamps
2:00 – PAGB’s digital health strategy
6:00 – The NHS app and self-care brands
12:00 – Self-care apps
15:30 – The importance of brands

Guest Bio
Michelle Riddalls OBE is chief executive officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.
Prior to joining PAGB, Riddalls was director of regulatory affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch.
Michelle has been recognized across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Over The Counter Special: Enabling Digital Self-Care, With PAGB’s Michelle Riddalls

Charles River’s CSO Julie Frearson outlines the FDA’s planned transition away from animal testing, changing attitudes to artificial intelligence, and the move to New Alternative Methods.

Charles River CSO Calls For Collaboration On Non-Animal Models

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 21, 2025. In this episode: obesity beyond GLP-1s; biotech leaders bullish as M&A heats up; BMS’s milvexian setback; clinicians on evolution of MASH treatment; and Japan H1 results mixed. 

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MXUR6OEDNNAEPPTTZ4YZKH55SU/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - Nov. 25, 2025

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月21日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本次要闻: GLP-1药物之外的肥胖治疗新局；并购热潮中生物科技巨头的乐观预期；百时美施贵宝Milvexian遭遇挫折；临床专家解读MASH疗法演进；日本企业上半年业绩喜忧参半。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MXUR6OEDNNAEPPTTZ4YZKH55SU/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

최근 런던에서 열린 Jefferies 글로벌 헬스케어 컨퍼런스를 취재한 Scrip기사를 요약한 내용입니다

https://insights.citeline.com/scrip/business/start-ups-and-smes/jefferies-25-biotech-leaders-bullish-as-ma-heats-up-EAHTR2MNHJE65E74WLIMBXXK5I/

 Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

 

글로벌 바이오 리더들, M&A 열기 속 낙관론 확산 (Korean-language podcast)

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 28, 2025. In this episode:  2027 Medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J’s Alzheimer’s asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas’s Padcev's first big win in bladder cancer study.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - Dec. 1, 2025

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月28日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本次要闻: 2027年医保降价幅度或低于CMS预期；赛尔安泰在DLL3肺癌ADC竞赛中领先；强生抗tau阿尔茨海默病药物posdinemab二期试验失败；拜耳阿苏德克赛安三期中风试验意外获胜；辉瑞/安斯泰来Padcev膀胱癌研究首获重大突破。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX



世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
今回取り上げた記事はこちら
「The Rise of China Biopharma – Five Themes In 2025（邦訳：中国バイオファーマの勃興　2025年注目のテーマ5つとは）」
URL: https://insights.citeline.com/scrip/r-and-d/clinical-trials/the-rise-of-china-biopharma-five-themes-in-2025-GEB2XLG3CNDONIO5HE4S2FZOVI/ 
※全文の閲覧には購読（有料）が必要です。
世界の製薬ビジネスメディアScrip（スクリップ）とは？
https://www.citeline.com/ja-jp/products-services/commercialization/scrip


【3分で解説  #世界のファーマ】第27回 中国バイオ企業の成長 5つのテーマ (Japanese-language podcast)

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form.

Compliance 360

Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s

Citeline

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