Yesterday, the FDA issued two draft guidance documents titled Development of a Shared System REMS (here) and Waivers of the Single, Shared System REMS Requirement (here). As the names may imply, if a shared system is possible, then that is the way an applicant should go, but if there are insurmountable hurdles to a shared system,
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.
The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals. While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals.
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 This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.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that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,
A long time ago, I was an expert witness in a pay-for-delay (reverse payment) case where, to me, the facts were clear. The patent settlement meant that the generic product would be assured entry into the market 5 years before the patent expired (can you guess what case that was?). In that case, I thought it was a no-brainer,
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”.
We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018.
Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA to meet GDUFA related goals;
In her new role, Linda will directly support the President and CEO serving as principal interface in key matters and delivering oversight across all Practice Areas, including program management of existing, new, and evolving projects. She will assist in the development of strategic plans and goals, advise on projects and critical issues, and continue to direct the on-going development of the Lachman brand and marketing strategy.
OGD topped the initial projection of both approvals and tentative approvals from my May 2 post (here) hitting 66 full approvals (predicted 62), and 16 tentative approvals (at the time there were only 9) for a total of 82 approval actions. This is good news for the generic industry, as it appears that each month OGD is moving back to its “new normal”.
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.