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News dal mondo

06

Apr

FDA - New Guidance for Industry on Generic Drug Development and Application Submission During the COVID-19 Public Health Emergency

On April 5, 2021, FDA published a new guidance for industry, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers. FDA has received questions from prospective applicants and applicants of abbreviated new drug applications (ANDAs) about generic drug product development and application assessment during the COVID-19 public health emergency. FDA has collected these questions and is providing the responses in this guidance document for the benefit of all stakeholders.

The guidance provides general recommendations in the form of questions and answers in topic categories including generic drug product development, ANDA submission and assessment, and marketing and exclusivity. FDA intends to revise and update this guidance as appropriate.

FDA recognizes that the COVID-19 public health emergency may impact the development of generic drug products, interrupt or delay ANDA applicants’ bioequivalence studies, and impact the submission of ANDAs to FDA for assessment. The ongoing development of generic drugs submitted as ANDAs to the FDA for assessment helps Americans continue to have access to safe, effective generic drugs....[FDA]

22

Apr

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

he European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete...

20

Apr

US GDUFA III: Use MDUFA model to create competition in generic drug markets

To design an effective financing system for generic drug approvals, the FDA must balance the need...

20

Apr

Pharmaceutical reshoring: a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies,...

19

Apr

Covid-19 ministro Speranza firma nuove Ordinanze per contenere la diffusione del virus

Il Ministro della Salute, Roberto Speranza, sulla base dei dati e delle indicazioni...

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