FDA Monographs and Current Regulations for Sunscreen Products
Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more...
Clinical Research Solutions
How to Survive a Multi-Year Consent Decree
Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year...
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
Clinical Research Solutions
FDA Approves Nasal Spray to Treat Depression in Adults
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
Clinical Research Solutions
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
Regulatory Sciences
FDA Draft Guidance on Tentatively Approved ANDA Submissions
On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...
FDA Prescription Drug User Fee Rates: Fiscal Year 2019
On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
Regulatory Sciences
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,...
Clinical Research Solutions
#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...
Clinical Research Solutions
#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...
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...
FDA Works to Reduce Medical Errors, Part One: Background & Overview of FDA’s Proprietary Naming Guidance
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
Cybersecurity in Medical Devices: Definitions from FDA's Draft Guidance
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...