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The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...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...
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...
Clinical Research Solutions
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On March 29, 2013, the FDA made available a draft guidance for Sponsors of biosimilar products outlining the procedures and processes for meetings with the FDA.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
Generic Drug User Fee Act (GDUFA) Overview
FDA user fees have been a fact of life for regulated industries for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you....
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...
Clinical Research Solutions
Label Changes Related to the QTc Interval
In a recent FDA Drug Safety Communication, the Agency announced that the Celexa (citalopram hydrobromide) label now has revised dosing recommendations based on evaluations of post-marketing reports...
Clinical Research Solutions
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...