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Seven Noteworthy 505(b)(2) Submissions
As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross...
View ArticleJanuary 23, 2017 – FDA Cuts Federal Register Wait for Certain ANDA Approvals
According to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety...
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Pharmacokinetics in Drug Development Related to ANDA/505(b)(2) Submissions
As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the...
View ArticleWhat is a Biosimilar and How Does it Differ Compared to Drug Development?
Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease,...
View ArticleBreaking Down Complex Generics
What are Complex Generics? Complex generics are those that are inherently difficult to duplicate, reviewed by CDER – OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs), are generally...
View ArticleHelp With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and...
As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This...
View ArticleFDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and...
FDA User Fees for Reliance on the FDA OTC Monographs? Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still...
View ArticleEMA Drug Post-Marketing Safety Surveillance Changes, US Impact and Compliance...
On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety...
View ArticleAn Introduction to Clinical Trials and Resources for Continued and...
In January 2018 this introduction to clinical trials was prepared by the pharmaceutical consultants at PDG who routinely design and write clinical trial protocols. This paper represents a collection of...
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What is an FDA U.S. Agent?
February 2, 2018: PDG® is a global pharmaceutical consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA...
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