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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.
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the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn.
Continuous process consultancy and operative innovations are part of the program
Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected
We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.
We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for
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In compliance with the Spanish Law 15/1999, of Protection of Personal Data and in accordance with regulations approved by the Spanish RD 994/1999 inform you that your data will be part of a file located in Friedrichsdorf (Germany), whose ownership belongs to Pharmalex Spain S.L.U. The purpose of these data is the insertion in a potential job selection process. Inform the user that at any time may exercise their right of access, rectification, and deletion of data through email curriculum@pharmalex.com or to this postal address Pharmalex Spain. Coso 103, 50001 Zaragoza, Spain.