Premier Consulting Blogs

31. Using The 505(b)(2) Pathway: Efficient Regulatory Approval For Combination Products 10/28/2021

    This blog post provides background on the regulatory submission and approval process for combination products and explores how developers may use a streamlined NDA process known as the 505(b)(2) pathway to reduce the size and/or scope of the nonclinical and/or clinical program for eligible combination products.

32. Referencing A Listed Drug For The 505(b)(2) Pathway 8/27/2021

    Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

33. Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies 8/27/2021

    As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is the final installment in the four part series of frequently asked questions (FAQs)

34. Back To Basics: 505(b)(2) FAQs Part 2: Clinical And Nonclinical Studies 8/27/2021

    As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is Part 2 in the series of frequently asked questions (FAQs).

35. Back To Basics: 505(b)(2) FAQs Part 1 8/27/2021

    The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway.

36. DART Studies: What Are They, And How Do They Fit Into Your Program? 8/27/2021

    Uncover how Development and Reproductive Toxicology studies are used to detect any effects of a drug within a complete reproductive cycle as relevant to humans.

37. The FDA's Technical Rejection Criteria For Study Data: Does Your eCTD Submission Comply? 8/27/2021

    To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now.

38. Pre-IND Meetings: How To Achieve Success For 505(b)(2) 8/27/2021

    One of the greatest mistakes that the sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Read about the tools for making the Pre-IND meeting successful.

39. 505(b)(1) Versus 505(b)(2): They Are Not The Same 8/27/2021

    The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same.

40. ANDA Or 505(B)(2): Choosing The Right Abbreviated Approval Pathway For Your Drug 7/29/2021

    For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Read about these in the available blog.