FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products
Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In 2017,...
Finding a Roadmap to Approval - Hint: You Can't Pick One Up at the FDA
Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...
7 Things to Consider Before Selecting a CRO
Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...
Quality & Compliance
Clinical Quality Systems & the Outsourced Model
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Senators work to Reform FDA’s Medical Device Inspection Process with Bipartisan Bill
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...
Regulatory Sciences
#2: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements
In 2013, the FDA released a guidance entitled "Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements." This guidance was finalized after...
#3: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled "Pediatric Study Plans: Content of and Process for Submitting...
#5: How to Comply with the Pediatric Research Equity Act
On September 7, 2005, FDA announced the availability of a draft guidance, entitled "How to Comply with the Pediatric Research Equity Act," providing sponsors with a number of recommendations...
#6: Expedited Programs for Serious Conditions – Drugs and Biologics
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an...
Quality & Compliance
#7: Quality Systems Approach to Pharmaceutical CGMP Regulations
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
#8: Special Protocol Assessment
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
Regulatory Sciences
#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations. The guidance, entitled Investigator...
Regulatory Sciences
Top Ten FDA Guidance Documents That You Should Know
There are a number of laws, regulations, and guidance documents ruling the pharmaceutical and biotechnology industries. Laws are passed by Congress and must be followed by the FDA. The Agency then...
FDA Addresses Extrapolating Adult Data for Pediatric Use
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
Tobacco Final Rule: Advice for Manufacturers
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...