Clinical Research Solutions
New 510(k) Guidance Bans 'Split Predicates'
Medical device manufacturers may need to re-think their approach to demonstrating substantial equivalence (SE) in the 510(k) notification process, due to the FDA’s recent finalization of the guidance...
Clinical Research Solutions
Monoclonal Antibody Sameness - Effects on Orphan Drug Development
We note with interest FDA’s recently released Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (April 2014). The guidance summarizes the...
Clinical Research Solutions
FDA Thinking on Biosimilar Immunogenicity Issues - A Case Study Based on the Enoxaparin ANDA Approval
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...
Clinical Research Solutions
What Can Testosterone Gels Teach Us About Abuse-Deterrent Opioids?
For most drugs, the process of developing and obtaining FDA approval of a generic version is simple and well-defined: sponsors must only prove that their product is pharmaceutically equivalent and...
Clinical Research Solutions
Rethinking the OTC Monograph System
When the OTC drug review was undertaken in the 1970s, it was deemed the best solution available at the time for efficiently assessing the safety and efficacy of the countless drug products being sold...
Clinical Research Solutions
FDA Revisits the Topic of INDs for Dietary Supplements
One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases,...
Clinical Research Solutions
FDA Issues a Reminder on Excipients in Dietary Supplements
In the new guidance on substances that can be added to foods, including beverages and dietary supplements, the FDA reminds manufacturers that the excipients added to oral dosage forms of these...
Clinical Research Solutions
Unapproved Codeine Products and Some DESI Drugs need FDA Approval or Cease Marketing
In a Federal Register notice published today, the Food and Drug Administration (FDA) announced its intention to take enforcement action against misbranded or unapproved prescription products...
Clinical Research Solutions
FDA Guidance Follows USP Salt Policy & Aims to Make Conversions Between Salt Forms Simpler
The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...
Clinical Research Solutions
Not a Bitter Pill to Swallow: FDA Releases Guidance on Size and Shape of Generic Drugs
In a Federal Register notice to be published on Dec. 10, 2013, FDA announced the release of a new guidance titled “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules.” The...