ASPHALION’s Post

📌 NEWS - FDA Guidance Update ↪ The FDA has just released a revision of the Guidance for Industry: Amendments to Abbreviated New Drug Applications (#ANDA) under #GDUFA (Revision 1). ↪ This updated guidance outlines the classifications and categories of amendments, explaining how #submissions may affect the goal dates for application assessments. It applies to amendments for both Abbreviated New Drug Applications (#ANDAs) and Prior Approval Supplements (#PASs), under Section 505(j) of the FD&C Federal Food, Drug, and Cosmetic Act. ↪ Submissions will now be classified based on their content, with goal dates set according to the assigned classification. 📄 Stay informed by reading the full guidance here: https://bit.ly/3XAWO0O #FDA #Pharma #ANDAs #DrugApproval #RegulatoryAffairs #GDUFA #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/4esrBDw

📌 NEWS - FDA Guidance Update ↪ The FDA has just released a revision of the Guidance for Industry: Amendments to Abbreviated New Drug Applications (#ANDA) under #GDUFA (Revision 1). ↪ This updated guidance outlines the classifications and categories of amendments, explaining how #submissions may affect the goal dates for application assessments. It applies to amendments for both Abbreviated New Drug Applications (#ANDAs) and Prior Approval Supplements (#PASs), under Section 505(j) of the FD&C Federal Food, Drug, and Cosmetic Act. ↪ Submissions will now be classified based on their content, with goal dates set according to the assigned classification. 📄 Stay informed by reading the full guidance here: https://bit.ly/3XAWO0O

FDA published new guidelines for Facility operations, methods, and product formulation. This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter) #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #ICH #regulatoryapplication #regulatoryapproval

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #ICH #usfda

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #ICH #usfda

Import alerts, warning letters, drug recalls — why ‘pharmacy to the world’ is facing US FDA heat #ImportAlerts #WarningLetters #DrugRecalls #PharmacyToTheWorld #USFDA #RegulatoryCompliance #QualityControl #PharmaceuticalIndustry #HealthcareRegulation #SupplyChainIssues #FDACompliance #GlobalTrade #DrugSafety #PublicHealth #MedicalRegulation #PharmaIndustry #QualityAssurance #FDAWarnings

The Medicines and Healthcare products Regulatory Agency has updated their guidance on good #pharmacovigilance practices that apply to #UK #marketingauthorisation holders and the licensing authority. The document describes the aspects of the respective European #GVP guidance that no longer apply to the #MHRA. The document has been updated to reflect the changes to UK legislation implementing new arrangements for medicines following the agreement of the Windsor Framework, and the European Union updates to GVP module XVI and Addendum II Updated to include new contact details. #brexit #pharma #pharmanews #pharmaindustry

📌Therapeutic Goods Administration (𝗧𝗚𝗔) 𝗔𝗱𝗼𝗽𝘁 𝟭𝟭𝟮 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀, enhancing the regulatory framework for therapeutic goods in Australia by leveraging the work done by international regulatory counterparts. 𝙃𝙚𝙧𝙚 𝙖𝙧𝙚 𝙩𝙝𝙚 𝙠𝙚𝙮 𝙩𝙖𝙠𝙚𝙖𝙬𝙖𝙮𝙨: 🔸 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗹𝗶𝗴𝗻𝗺𝗲𝗻𝘁: The TGA aligns with international regulatory counterparts, such as the European Union (EU) Guidelines, International Conference on Harmonisation (ICH), and the Food and Drug Administration (USA). 🔸𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗔𝗱𝗼𝗽𝘁𝗶𝗼𝗻: Before adopting any guideline, the TGA undertakes extensive internal and external consultations to ensure consistency with Australian requirements. 🔸𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀: The guidelines apply not only to prescription medicines but also to over-the-counter (OTC), complementary, and some listed medicines. 🔸𝗗𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻 𝗝𝘂𝘀𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: While the guidelines are not mandated by legislation, any deviation from them in an application must be justified. This reflects a move towards a harmonized approach to regulatory guidance globally. 𝙃𝙚𝙧𝙚'𝙨 𝙩𝙝𝙚 𝙇𝙞𝙣𝙠🔗: https://lnkd.in/eAaj3nK6 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

🚨 Addressing the Growing Concern of Poor Quality Drugs 🚨 The recent rise in the availability of substandard medications like Spurious and other cheap alternatives is a serious cause for concern in the healthcare industry. These drugs not only jeopardize patient health but also erode trust in the pharmaceutical sector as a whole. It is high time for manufacturers, regulatory bodies, and industry leaders to come together to ensure that quality and ethics remain at the core of drug production. 🔍 Manufacturers: Cutting corners on production processes, sourcing substandard ingredients, or failing to adhere to good manufacturing practices (GMP) is simply unacceptable. Patient safety must always come first. By investing in quality, you are not only safeguarding public health but also protecting your brand’s reputation in the long run. 🛡️ FDA and Regulatory Bodies: It’s critical that you take stronger actions to monitor and enforce the revised Schedule M guidelines. These regulations exist for a reason — to ensure that drugs produced and distributed are safe, effective, and of the highest quality. Active, consistent monitoring and swift enforcement can make a huge difference. 💡 The path to improving healthcare lies in ethical practices, strict adherence to regulations, and transparency at every level of the supply chain. Let’s collaborate to protect the integrity of the pharmaceutical industry and, most importantly, the lives of the patients we serve. Together, we can raise the standard and ensure that quality is never compromised. #PharmaceuticalQuality #PatientSafety #EthicalManufacturing #ScheduleM #GoodManufacturingPractices #Healthcare #FDA #DrugRegulation #PharmaIntegrity #PublicHealth

What is an FDA Post-Warning Letter Meeting? The U.S. Food and Drug Administration (FDA) issues Warning Letters to companies or individuals when it believes there are violations of federal law related to the safety and effectiveness of drugs, medical devices, or other products within its regulatory purview. Most of these are issued following an inspection. When reading FDA Warning Letters, you might have recognised that under the program enhancements for the Generic Drug User Fee Amendments (GDUFA or GDUFA III Commitment Letter), the facility may be eligible for a so-called Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of the company's corrective action plans. A Post-Warning Letter Meeting refers to a meeting that can take place between the FDA and the recipient of a Warning Letter after the letter has been issued. The purpose of such a meeting is typically to discuss issues raised in the Warning Letter, address open concerns outlined by the FDA, and establish a path forward for corrective actions. So, the company has the opportunity to present their perspective, provide additional information, and discuss corrective action plans. It is a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA). #pharmaceuticals #FDA #Warningletter #compliance #Drugsubstance #Drugproduct