Zifo Compliance Solutions’ Post

FDA has issued a draft guidance for the industry to provide recommendations for documenting minor labeling changes in their next annual report. An applicant can propose labeling changes after NDA or ANDA approval, which are categorized as major, moderate, or minor. ➡ Minor changes include certain changes that have minimal potential to an adverse effect on the drug product's identity, strength, quality, purity, or potency. ➡ The applicant may implement minor changes to an approved NDA or ANDA immediately without submitting a supplement to FDA. However, it must document such minor changes in its annual report. Stay informed with the latest FDA updates to industry by checking out the draft guidance now. https://lnkd.in/eDzVS9rK

In this Weekly Supplement, we provide the first part of our coverage of a panel session at the 2024 CASSS WCBP Conference, which brought together regulators from five different regulatory agencies and WHO to discuss “transforming global regulatory CMC practices in an age of regulatory innovation.” We focus in this first part on the summary remarks provided by each of the panelists on the engagement of their respective agencies/organization with the evolving CMC practices and international collaborative initiatives. The Q&A discussion that followed at the session will be reviewed in our next issue. Our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports (NCRs) that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting. Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week. Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star. Read more: https://lnkd.in/eqMKu5XQ For information on recent global CMC/GMP developments, see IPQ’s “Updates in Brief:” https://lnkd.in/eFMTc5Cy   For a look at drug product recalls included in FDA’s weekly enforcement reports, visit IPQ’s recalls page: https://lnkd.in/erwpmUni   Subscribers can also read summaries and click through to recently issued FDA warning letters: https://lnkd.in/e8ppjyv7   If your organization is an IPQ subscriber or partner, you may create a personal username and password. See how: https://lnkd.in/d56q2Ph2   Login today!

FDA Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry https://lnkd.in/faMsqTY #FDA #regulatoryaffairs #healthcareinnovation #publishing #guidance #manufacturing #healthandwellness #medicalproducts #US

Did you know that FDA sometimes holds regulatory meetings to discuss a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) inspection outcome with the inspected drug manufacturer? What is the purpose of these meetings and how do they differ from one another and other regulatory meetings?

Providing regulatory submissions in electronic format just got easier. The FDA has established new requirements for electronic submissions of investigational new drug application safety reports. This guidance describes the electronic format sponsors will be required to use when submitting serious and unexpected suspected adverse reactions. These new requirements are being established under section 745A(a) of the Federal Food, Drug, and Cosmetic Act. Stay up-to-date with the latest FDA regulations and guidelines to ensure your submissions are in compliance. #FDA #IND #regulatorysubmissions #electronicformat #safetyreports #compliance

In the world of #drugdevelopment, tapping into FDA insights before submission can save time, resources, and boost your chances of regulatory approval. A pre-NDA meeting can prove exceptionally valuable – find out more: https://bit.ly/3tWfVor #FDA #PreNDAMeeting

In this Weekly Supplement, we provide the second part of our coverage of a panel session at the 2024 CASSS WCBP Conference, which brought together regulators from five different regulatory agencies and WHO to discuss “transforming global regulatory CMC practices in an age of regulatory innovation.” The first part focused on the summary remarks provided by each of the panelists on the engagement of their respective agencies/organization with the evolving CMC practices and international collaborative initiatives. Part II reviews the Q&A discussion that followed at the session in which the panelists had a chance to dig deeper into some of the key issues and developments in the international collaboration arena. Our Weekly Supplements include a summary listing of the “News in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports (NCRs) that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting. Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week. Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star. Read More: https://lnkd.in/eevMWs8C For information on recent global CMC/GMP developments, see IPQ’s “Updates in Brief:” https://lnkd.in/eFMTc5Cy   For a look at drug product recalls included in FDA’s weekly enforcement reports, visit IPQ’s recalls page: https://lnkd.in/erwpmUni   Subscribers can also read summaries and click through to recently issued FDA warning letters: https://lnkd.in/e8ppjyv7   If your organization is an IPQ subscriber or partner, you may create a personal username and password. See how: https://lnkd.in/d56q2Ph2   Login today!

Ensuring drug safety is critical across markets. Both the US FDA and EU EMA have rigorous GVP systems, from FAERS and REMS to EudraVigilance and RMPs, safeguarding patients. Discover how Freyr can help navigate these Regulatory frameworks with cutting-edge solutions. https://lnkd.in/gjtPYEAB   #Pharmacovigilance #DrugSafety #GVP #FreyrSolutions

Ensuring drug safety is critical across markets. Both the US FDA and EU EMA have rigorous GVP systems, from FAERS and REMS to EudraVigilance and RMPs, safeguarding patients. Discover how Freyr can help navigate these Regulatory frameworks with cutting-edge solutions. https://lnkd.in/gjtPYEAB #Pharmacovigilance #DrugSafety #GVP #FreyrSolutions

🎯Key Takeaways from the PDA-FDA Joint Regulatory Conference. Zephaniah Christopher C. Odidika and I recently attended the PDA - Parenteral Drug Association - FDA Joint Regulatory Conference, where we gained crucial insights and updates from the FDA and Industry leaders. Some of the largest takeaways: 🏢Regornization of the Office of Regulatory Affairs (FDA-ORA) The ORA will undergo significant structural changes impacting thousands of employees. The reorganization aims to streamline compliance functions and is set to occur on October 1. 📈 Updates from Agencies Focus on specific product groups was highlighted, such as eye drops; the FDA has published a list of misbranded and recalled over-the-counter eye drops sold at major retailers. 💽Data Integrity and Virtual Inspections 1/5 of CGMP warning letters still mention some form of data integrity. Remote document inspections and hybrid approaches began at the start of the pandemic, and their future use was discussed. 💬Comment 'Data', and I will happily PM all citations and my full notes document from the conference.