Pre-IND Meetings
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).
Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
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…
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Clinical Trial Design
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 scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include, among…
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Pharmaceutical Development Programs: Implementation and Oversight
The importance of pharmaceutical industry experience at this critical juncture in the drug development program cannot be understated.
Strategic Drug Development Services
PDG navigates the complexities of the US pharmaceutical industry for clients through our strategic drug development services that include analysis of commercial potential during early stages of clinical development in parallel with regulatory planning.
Generic drug manufacturers could face new regulatory requirements from FDA
FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…
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Generic Labeling Inconsistent with Reference Listed Drug 78% of the Time
A recent study found that 78% of generic drug labels are inconsistent with the labeling of the reference listed drug (Duke et. Al 2012). While most of the differences were relatively minor, nearly one in ten were off by more than ten side effects. The researchers reviewed 9,105 labels representing over 1,500 drugs on DailyMed,…
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FDA Announces User Fees for Drugs, Devices, Biosimilars
The FDA Safety and Innovation Act (FDASIA) contains 140 pages of changes to the pharmaceutical industry, including a pronounced change to User Fees for Published Drugs and Biosimilar Products. These changes may have quite an impact on your strategic development plans, which addressing sooner rather than later can have a effect on your bottom line. …
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A Regulatory Affairs Consultant’s eCTD Update
According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory agencies around the world.” FDA’s CDER and EMA have mandated eCTD specifications for all electronic submissions. FDA is forecasting mandates for electronic-only submissions for Abbreviated New Drug Applications (ANDA) and type II Drug Master Files (DMF), Biologics License…
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As Expected, User Fee Bill Passes House Heads for Senate
The Food and Drug Administration Safety and Innovation Act (FDASIA) goes to the Senate for a vote next week after passing by a large margin in the House June 20. The new user fee legislation will result in a number of changes at FDA including generic user fees. At the current pace, signature into law…
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