FDA releases draft guidance on information requests and discipline review letters

The US Food and Drug Administration (FDA) has released draft guidance which establishes a new type of letter the agency sends to generic drug manufacturers to provide applicants with initial thoughts on possible deficiencies of an abbreviated new drug application (ANDA). The FDA will issue discipline review letters (DLRs) and information requests (IRs) to attain further information or clarification to ensure completion of a discipline review. Read more “FDA releases draft guidance on information requests and discipline review letters”

ACSS Consortium launches Generic Medicines Work Sharing Trial

To facilitate mutual interests in marketing authorisation applications for generic medicines, the ACSS Consortium has launched the Generic Medicines Work Sharing Trial (GMWST). The GMWST is a new work sharing model for the coordinated assessment of a generic application that has been filed with multiple ACSS Consortium agencies. Read more “ACSS Consortium launches Generic Medicines Work Sharing Trial”

FDA has updated the Orange Book with patent submission dates

The US Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the “Orange Book”, by adding patent submission dates. The FDA has published this data with the aim of increasing transparency and generic drug competition. The addition of patent submission dates may help generic drug manufacturers determine the earliest date when they may be able to market new generic medicines. Read more “FDA has updated the Orange Book with patent submission dates”

FDA publishes draft guidance on determining whether to submit an ANDA or a 505(b)(2) application

In a new draft guidance document, the US Food and Drug Administration (FDA) explains both the pathways by which abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The guidance document includes information to assist applicants in determining which type of application is appropriate. Read more “FDA publishes draft guidance on determining whether to submit an ANDA or a 505(b)(2) application”

New online portal for requesting pre-ANDA meetings for complex generic medicines with the FDA

With the new Generic Drug User Fee Act (GDUFA II) coming into play, the US Food and Drug Administration (FDA) have launched a new online portal which allows for companies to set up pre-ANDA (abbreviated new drug application) meetings. Read more “New online portal for requesting pre-ANDA meetings for complex generic medicines with the FDA”