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...
Clinical Research Solutions
FDA Proposes Controversial Rule Allowing ANDA Applicants to Change Drug Labels
On Nov. 13, 2013, the Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register. The title of the Proposed Rule is “Supplemental Applications Proposing Labeling Changes for...
Waivers for Carcinogenicity Studies? Not So Fast!
The recently published request for comments regarding the Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals signals intent by regulatory agencies to alter what Sponsors consider in...
Regulatory Sciences
FDA Releases New Guidance on Meetings with Sponsors of Biosimilars
On March 29, 2013, the FDA made available a draft guidance for Sponsors of biosimilar products outlining the procedures and processes for meetings with the FDA. Although much of guidance for the...
Clinical Research Solutions
Extended Review Timeline for Certain Applications under Proposed PDUFA V
The Prescription Drug User Fee Act (PDUFA) is due to be reauthorized by the end of September this year. Along with the usual increases in fees, the latest version of the act (PDUFA V) includes some...
FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers
In March 2011, the Tobacco Products Scientific Advisory Committee released a report on the impact of menthol on public health. Based on the committee’s review of all available evidence, they...
Cetero FDA Action
If your company has used Cetero Research's Houston facility to conduct bioanalytical studies between April 1, 2005 and June 15, 2010, your marketing applications may need to be repeated or confirmed....
Clinical Research Solutions
GRAS List Substances: Background and Misconceptions
Although it is widely known that the acronym GRAS stands for “Generally Recognized as Safe”, many individuals believe that GRAS substances have been rigorously reviewed for safety and approved for...
Food and Cosmetic Ingredients that are also Excipients in Drug Products – OGD Policy
In a recent teleconference with senior officials in the Office of Generic Drugs (OGD) at the FDA, it was conveyed that it is the policy of OGD in determining the safety of excipients to rely...
Innovation vs. Safety: Another Definition for the “Chicken or the Egg”
We all know that the FDA’s mission is to promote and protect public health. However, in their effort to protect the public health, it seems that they may be inadvertently harming the industry that...
Competition Between Orphan Drug Sponsors – Good for Patients, Strategic Complexities for Sponsors
The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...