##  [Regulatory Roundup - July 15, 2024](/index%2ephp/regulatory-roundup/week-of-july-15-2024) 

[Back to Regulatory Roundup Archive](/regulatory-roundup)



## Top Industry News

- [ANVISA Publishes Standard Operating Procedure for the Medicines Area](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-publica-procedimento-operacional-padrao-para-area-de-medicamentos)
- [MDA Malaysia Announcement: Pilot Survey for Unique Device Identification (UDI) in Malaysia](https://portal.mda.gov.my/index.php/announcement/1432-announcement-pilot-survey-for-unique-device-identification-udi-in-malaysia)
- [ASA Bans Misleading Ads by Nutritional Sciences Ltd for Arthritis Treatment Claims](https://www.asa.org.uk/rulings/nutritional-sciences-ltd-g24-1241706-nutritional-sciences-ltd.html)
- [EU Approves Addition of Milk Iron Caseinate to Food and Supplements](https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=OJ:L_202401821)
- [FDA Draft Guidance on Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products](https://www.fda.gov/media/179858/download)
- [Public Consultation for ICH Guideline M14 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” Opened in Switzerland](https://www.swissmedic.ch/swissmedic/de/home/news/mitteilungen/public-consultation-fuer-ich-guideline-m14.html)
- [FDA Guidance on Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions](https://www.fda.gov/media/179983/download)
- [Costa Rica Regulates the Use of Cannabis and Hemp in Food](https://members.wto.org/crnattachments/2024/TBT/CRI/24_03911_00_s.pdf)
- [EU Ecodesign for Sustainable Products Regulation (ESPR) Published](https://www.ctpa.org.uk/news/eu-ecodesign-for-sustainable-products-regulation-espr-published-7845)
- [FDA Guidance on Dental Curing Lights - Premarket Notification (510(k)) Submissions](https://www.fda.gov/media/179991/download)
- [BPOM Issues Regulation No. 10 of 2024 on Marking Natural Ingredients, Quasi-Drugs, and Health Supplements for Consumer Protection](https://standar-otskk.pom.go.id/berita/perbpom-no-10-tahun-2024)
- [AICIS-From 1 July 2024, Use of Chemicals as Vaping Goods, or in Vaping Goods, is a Therapeutic Use and Not an Industrial Use](https://www.industrialchemicals.gov.au/news-and-notices/)
- [FDA Guidance on Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder](https://www.fda.gov/media/170561/download)

## Mergers & Acquisitions

- [Merck Completes Acquisition of EyeBio](https://www.merck.com/news/merck-completes-acquisition-of-eyebio/)



## Upcoming Events

- [DIA India Annual Meeting 2024](https://www.diaglobal.org/en/conference-listing/meetings/2024/09/confluence-of-care-pharmacovigilance-clinical-innovation-regulatory-sciences-and-medical-devices-elevating-patient-safety)
- [The MedTech Conference](https://themedtechconference.com/)
- [International Conference on Cosmetic Dermatology and Laser Surgery (ICCDLS - 24)](https://www.iirst.com/event/index.php?id=2416493)

## Blogs

- [Streamlining eCTD Submissions with Regulatory Software: A Comprehensive Guide for the Life Sciences Industry](https://www.freyrsolutions.com/blog/streamlining-ectd-submissions-with-regulatory-software-a-comprehensive-guide-for-the-life-sciences-industry)