FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity.  FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to…Details
In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014.…Details
PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a chronology of events related to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information. Subsequently, RAPS Regulatory Focus (Alexander Gaffney, RAC, October 7, 2014) reported that…Details
FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product approved via a 505b2 NDA. In July 2014, FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s (NDA 202763) approved in February 2012. …Details
As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues. As such, we have followed with great interest the proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” For ease of reference, we’re going to begin to refer to it as the…Details
PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.
The staff at PDG is highly proficient in the compilation of targeted and effective Citizen Petitions addressed to FDA. PDG has participated in the compilation, submission and maintenance of multiple petitions. The topic areas have been many and varied including, for example, ANDA suitability petitions, requests for changes in drug labeling, generic drug review standards…Details
PDG’s team of industry professionals has extensive experience in planning Pre-IND Meetings on our clients’ behalf (as well as other Type B Meetings).
First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies and Pre-IND Meetings for a…Details
PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of pharmaceutical scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include,…Details