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Don’t risk withdrawal of your ANDA by FDA!
An Abbreviated New Drug Application (ANDA) is an application for US generic drug approval for an existing licensed medication or approved drug. According to Guidance for Industry – Changes to an Approved NDA or ANDA, any changes to an approved ANDA or New Drug Application (NDA) must be reported to the FDA.
- Major change: Prior Approval Supplement (PAS, approval required)
- Moderate change: Supplement – Changes Being Effected in 30 Days (CBE-30, “tell, wait & do”)
- (Moderate change: Supplement – Changes Being Effected (CBE-0, “tell & do & may cease”)
- Minor change: Annual Report (“do & tell”)
Code of Federal Regulations 21 CFR 314.81 requires an applicant to submit an annual report for every approved NDA and every ANDA. If not done: FDA may withdraw your NDA / ANDA
The US Food and Drug Administration (FDA) announced in early 2020 that it plans to withdraw the approval of 249 Abbreviated New Drug Applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for their generic drugs.
FDA Code of Federal Regulations (21 CFR 314.81) requires that all ANDA / NDA-holders must submit an annual report for each approved marketing application – if this is not done the FDA may rescind your NDA / ANDA approval. Accordingly, the FDA maintains that manufacturers will have the opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn.
- Ensuring regulatory compliance for your supplements and annual reports
- Supplements & annual reports
- Health authority contact
- Classification and categorization
- Prepare submission strategy for US (and worldwide)
- If applicable, align global implementation strategy, including compilation, submission and follow-up procedures
- FDA gateway submission and tracking
- Technical authoring of content
- CMC writing services: compilation of quality dossiers (M3 and M2.3)
- Product Information Management and labeling/SPL
- Regulatory expertise on a daily basis
- Providing US and global regulatory strategy and intelligence
- Provide regulatory expertise and support to all functions within client company (manufacturing site, quality, pharmacovigilance, etc)
- Gap analysis, global roll out strategies, change control review
- Fill in with experienced regulatory staff for staff shortages, maternity leaves, medical leaves, etc.
- Extend compliance by taking full regulatory responsibility for parts of your portfolio
- All maintenance activities (REG submissions, CMC, labeling, data capture, …) handled by PharmaLex on a global and / or country level, with interfaces to different customer functions such as marketing, local affiliates, manufacturing sites and medical affairs as well as national regulatory authorities
- Program governance structure with clear roles and responsibilities
- Product teams with experts and interfaces to client
- Program manager for strategic discussions
- Upper management steering committee and decision board for strategic decisions
- Controlling and performance measurement via defined budget & KPIs
- Flexible staffing to meet arising project needs
- Ensure project continuity with backup staff to manage peak workload activities (“Breathing Organization”)
- Not necessarily one-to one staffing of client roles to gain efficiencies
- “Breathing Organization” – Up-scaling and down-scaling of teams as needed
Continuous process consultancy and operative innovations are part of the program
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What was especially important to me was their ability to get a team, with the right experience, together so quickly.
Mid-size Biotech
Head of Outsourcing
Head of Outsourcing
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
Large Pharma, Global
VP Regulatory Strategy
VP Regulatory Strategy
