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, and there were 39 new […]
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 […]
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. As the guidance document notes, […]
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 […]
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 This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.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 […]
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 […]
Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.” FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document. The Q&A document referenced above responds to those questions. […]
On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”. The original guidance was published November 13, 1998. The revision spans some 50 pages of discussion about critical quality […]
Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ). The testimony addresses the following major points. It is critical that we combat the […]
Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu. The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms. In addition, they also warn patients to be wary […]
