Quality & compliance
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Learn MoreBiosimilars in the time of COVID-19 and beyond
Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...
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Learn MoreConsiderations for protecting your business and employees from COVID-19
This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.
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Learn MoreUnderstanding the COVID-19 regulatory procedures the FDA is using
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
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Learn MoreRestricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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Learn MoreUnderstanding Department of Justice Enforcement Policies relating to FDA-Regulated Products
At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...
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Learn MoreWhat Influences the Compliance Culture at FDA?
The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization. It has hundreds of personnel who are...
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Learn MoreFDA & Nitrosamine Impurities – The Proverb of the King with Long Arms
If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here). Over time it has developed into the commonly recognized idea...
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Learn MoreAs PIC/S expansion continues, what does this mean for manufacturers seeking to join?
Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...
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Learn MoreIt’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too
In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...
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Learn MoreBetween Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities
In January 2020 the Food and Drug Administration (FDA or “agency”) published the revised draft guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing...
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Learn MoreBeware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!
Donor Eligibility (DE) determination is a central aspect of how FDA and other regulatory authorities ensure that a product from a single allogeneic donor has acceptable very low risk of...
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Learn MoreFDA Inspections and Cleaning
Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection. Often cleaning validation studies are extensively...
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Learn MoreCan FDA Really Do That? Understanding FDA’s Jurisdiction
On August 29, 2019 the US FDA sent a Warning Letter to Shanghai Institute of Pharmaceutical Industry (SIPI) (see the Warning Letter). The FDA charged the firm with refusing a pre-announced...
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Learn MoreCritical Differences Between a Form FDA 483 and Warning Letters
There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...
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Learn MoreDoes FDA Consistently Assess Product Quality Risk and Control in Applications?
Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...
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Learn MoreWill FDA Withdraw an Approved Application Over Product Quality Problems?
There have been some recent headlines where the acting FDA Commissioner and other senior agency officials have stated that the FDA will consider the use of its full authorities to take...
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Learn MoreDon’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t
In a recent blog post, I wrote about how manufacturers can overcome data integrity problems that potentially imperil an application’s approval and commercializing a product. Sometimes...
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Learn MoreNew PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management
On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...
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Learn MoreDemystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...
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Learn MoreFacilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...
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