##  [Regulatory Roundup - Aug 26, 2024](/index%2ephp/regulatory-roundup/week-of-aug-26-2024) 

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



## Top Industry News

- [FDA Guidance on Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA](https://www.fda.gov/media/165468/download)
- [Malaysia MDA Approach for New and Re-Registration of Medical Devices with Expired EC Certificates and Self-Declared Class B IVD](https://portal.mda.gov.my/index.php/doclink/announcement-update-mda-approach-for-new-and-re-registration-of-medical-devices-with-expired-ec-certificates-and-self-declared-class-b-ivd-revision-22082024-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJhbm5vdW5jZW1lbnQtdXBkYXRlLW1kYS1hcHByb2FjaC1mb3ItbmV3LWFuZC1yZS1yZWdpc3RyYXRpb24tb2YtbWVkaWNhbC1kZXZpY2VzLXdpdGgtZXhwaXJlZC1lYy1jZXJ0aWZpY2F0ZXMtYW5kLXNlbGYtZGVjbGFyZWQtY2xhc3MtYi1pdmQtcmV2aXNpb24tMjIwODIwMjQtcGRmIiwiaWF0IjoxNzI0MzEyMTYyLCJleHAiOjE3MjQzOTg1NjJ9.MO0ftXYC80EKwC1P5ZG4tKut-pNklrmmvPF9MYDWJHA)
- [FSANZ-Notification Circular - 298-24 \| Food Standards Australia New Zealand](https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-298-24)
- [ANVISA Launches Guidelines for Inspection of Clinical Analysis Services and Welcoming Therapeutic Communities](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-lanca-roteiros-para-inspecao-em-servicos-de-analise-clinica-e-comunidades-terapeuticas-acolhedoras)
- [FDA Guidance on Mammography Quality Standards Act and Regulation Amendments](https://www.fda.gov/media/181152/download)
- [ANVISA Reissues Rule that Simplifies Rules for Registration and Import of Medicines and Vaccines](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/mpox-anvisa-reedita-norma-que-simplifica-regras-para-registro-e-importacao-de-medicamentos-e-vacinas-1)
- [MHRA Guidance on Good Laboratory Practice (GLP) for Safety Tests on Chemicals](https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals)
- [FDA: Electronic Submission Template for Medical Device De Novo Requests](https://www.fda.gov/media/172450/download)
- [FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act](https://www.fda.gov/media/78456/download)
- [FDA: Predetermined Change Control Plans for Medical Devices](https://www.fda.gov/media/180978/download)
- [TGA - Post-Market Review of Spinal Cord Stimulator Devices](https://www.tga.gov.au/news/news/post-market-review-spinal-cord-stimulator-devices)
- [Chile- Decree 47 Exempt Modifies Technical Standard No. 209, of 2020, Which Sets Maximum Limits of Pesticide Residues in Food, Approved by Resolution No. 892, of 2020, of the Minsal](https://www.bcn.cl/leychile/navegar?i=1205503)
- [Health Canada- Proposed Maximum Residue Limit PMRL2024-04, Fluopyram](https://www.canada.ca/content/dam/hc-sc/documents/services/consumer-product-safety/pesticides-pest-management/public/consultations/proposed-maximum-residue-limit/2024/fluopyram/document-eng.pdf)
- [Update on OPSS product safety alerts and reports of cosmetic products posing a risk to the health and safety of consumers](https://www.gov.uk/guidance/product-recalls-and-alerts)
- [CTPA - EC Working Group on Cosmetics 13/14 June 2024](https://www.ctpa.org.uk/news/ec-working-group-on-cosmetics-1314-june-2024-7879)
- [EU Safety Gate Alerts July 2024](https://ec.europa.eu/safety-gate-alerts/screen/webReport)
- [International Fragrance Association (IFRA) has published its new IL on new ingredients self-classified as Toxic for Reproduction (CMR) Category 2 to be added to the IFRA-IOFI Labelling Manual 2024](https://www.ctpa.org.uk/news/ifra-letter-update-7892)
- [EU Introduces New Regulation on Maximum Nickel Levels in Food, Effective July 2025—32 Food Categories Impacted](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1987&qid=1723015907852)



## Blogs

- [Impact of Sustainability on Food Products and Dietary Supplements: A Regulatory Perspective in Japan](https://www.freyrsolutions.com/blog/impact-of-sustainability-on-food-products-and-dietary-supplements-a-regulatory-perspective-in-japan)