In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.
FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product. However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement actions related to the use of multi-component compounded products thought to artificially increase billing rates for these compounded products.
Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here),
Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages. Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary to provide a link to Dr.
The Report on Drug Shortages for Calendar Year 2017 (here), which is required by Section 506C-1 of the Federal Food, Drug and Cosmetic Act, issued last Thursday, and describes some real progress in the drug shortage arena.
The report notes that “][d]uring 2017, FDA helped prevent 145 potential new shortages,
Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program. The proposals (here) include regulatory and review process changes, as well as organizational restructuring. The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development.
This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission.
The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application.
During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.
There are three lifecycle phases:
- Procedure Design and Development
- Procedure Performance Qualification
- Continuous Procedure Performance Verification
A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).
Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.” This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized. For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,
The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age. FDA also warns this is not just a problem with younger age groups. The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly after use and can lead to serious and life-threatening consequences
FDA is asking all manufacturers to review labeling to include warnings about the event as they continue to monitor the situation,
The FDA has revised and finalized its previously issued (2011) Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry. FDA notes that “this guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective.” The Agency also indicates that several rulemaking activities will also be initiated that will address these products.
Since the 1938 United States Food, Drug and Cosmetics Act was put in place, legal requirements have existed mandating the integrity of the manufacturing and laboratory data supporting product quality and ensuring patient safety. However, only within the last 10 years has the topic of data integrity been widely discussed and numerous guidance documents (draft and final) have been published.
Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval. The FDA has taken this extraordinary approach to provide greater transparency regarding this issue.
Since its appearance in August 2007, the Guidance for Industry, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients has stood the test of time in providing clear and practical guidance to the pharmaceutical industry, as described in the guidance’s original objective, “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality”.
Having attended several conferences where the topic of DSCSA has been discussed, and listening to leading vendors (those that provide both hardware and software) opining on how the industry is behind the eight ball in obtaining equipment and full integration, and validation due to long lead times with the number of vendors available, it appeared logical that a document on the availability of waivers might be in the cards.