The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to PMBOK. This article presents opportunities for using a project management framework when strategizing for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and t...

Generic drug makers received a refreshed draft guidance from the US Food and Drug Administration on Friday; the guidance updates some recommendations on the conduct of bioequivalence (BE) studies that have pharmacokinetic endpoints.   In announcing the updated draft guidance’s availability, FDA said that the document is meant to "clarify the agency’s recommendations regarding BE information submitted in an [abbreviated new drug application] submission, provide assistan...

This article discusses formal meetings and controlled correspondence for the generic drug industry and the use of these regulatory tools in the abbreviated new drug application (ANDA) process. The author notes that these tools are useful in understanding the current thinking of the US Food and Drug Administration (FDA) to avoid unexpected delays for product approval as well as expedite faster generic drug approvals.   Introduction Generic drugs are copies of innovato...

After the US Food and Drug Administration (FDA) discovered an abbreviated new drug application (ANDA) relied on data from a disreputable contract researcher, and after repeated attempts over five years to get the company to resubmit new data, the agency on Friday proposed to withdraw the approval for Cipla subsidiary InvaGen Pharmaceuticals’ trandolapril tablets. “The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data...

For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...

Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...

Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force expressed disappointment that, although it participated in the Generic Drug User Fee Amendments (GDUFA II) negotiation...

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments. The draft explains when ANDA amendments will be designated as either standard or priority review, classified as either major or minor and receive a goal date based on certain factors, including whether a preapproval ins...

As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...