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CDER Update May/June 2017
9/8/2017 9:20:48 AM

·         Activities Report of the Generic Drug Program (FY 2017) 



·         Office of Pharmaceutical Quality - Emerging Technology Program promotes the adoption of innovative approaches to pharmaceutical manufacturing.




This guidance describes the process through which prospective generic drug applicants submit pre-submission facility correspondence (PFC) in advance of priority generic drug submissions.




CBER Update May/June 2017
9/8/2017 9:19:32 AM

·         February 8, 2017 Transcript - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (PDF - 2.7MB) 


·         February 9, 2017 Transcript - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (PDF - 1.4MB) 


·         Use of Symbols in Labeling 


·         Submitting Field Alert Reports (FARs) to CBER 

CDRH Update May/June 2917
9/8/2017 9:17:48 AM




SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of  Electronic Records and Electronic Signatures in Clinical Investigations  under our regulations--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other  interested parties on the use of electronic records and electronic  signatures under our regulations in clinical investigations of medical  products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records;  Electronic Signatures--Scope and Application'' issued in August 2003  (referred to as the 2003 part 11 guidance) for recommendations that  pertain to FDA-regulated clinical investigations conducted under our  regulations.
To ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017.



The Food and Drug Administration (FDA, the Agency, or we) is  announcing the following public workshop entitled ``Antimicrobial  Susceptibility and Resistance: Addressing Challenges of Diagnostic  Devices.'' The purpose of this workshop is to discuss potential  scientific and regulatory challenges associated with developing  traditional antimicrobial susceptibility testing (AST) devices and  devices that detect antimicrobial resistance markers by molecular or  novel diagnostic technologies, and to provide an overview of relevant  provisions of the 21st Century Cures Act that may impact the  development of such devices. Public input and feedback gained through  this workshop will aid in the development of science-based approaches  to regulatory decisionmaking regarding traditional and novel AST  devices. Further, this workshop will explore opportunities for the  efficient development and evaluation of AST devices, which may lead to  better patient care and reduce antimicrobial resistance through  improved antibiotic stewardship.  DATES: The public workshop will be held on September 13, 2017, from  8:30 a.m. to 5 p.m.


SUMMARY: The Food and Drug Administration (FDA or Agency) has  determined that it is necessary for manufacturers of certain reusable  medical devices to include in their premarket notifications (510(k)s)  instructions for use which have been validated and validation data  regarding cleaning, disinfection, and sterilization, for which a  substantial equivalence determination may be based. This notice  includes a list of these reusable devices that will require validated  instructions for use and validation data in their premarket  notification. FDA is publishing this list in accordance with the  requirements established by the 21st Century Cures Act. This action  ensures that the premarket requirements for these device types are  clear and predictable which facilitates more efficient review of these  510(k)s.  DATES: These actions are effective on August 8, 2017.


·         Federal Register: Humanitarian Use Devices; 21st Century Cures Act; Technical Amendmen

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures  Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices  have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.

Impact of Multi-Attribute Testing in the Biopharmaceutical Industry
8/24/2017 1:17:42 PM

I was fortunate to work with Bill Paulson in writing an article “Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC” published in IPQ (International Pharmaceutical Quality) August 7, 2017.  I refer people to that article for the specifics of MAM and in this blog I will touch upon the business and strategic impact of multi-attribute methods (MAM) given the apparent inevitable implementation of MAM.

MAM utilizes mass-spectrometry to analyze biopharmaceuticals and is on the cusp of being ready for full implementation into development and QC (see IPQ article) and seems certain to become the primary biopharmaceutical method in coming years.  MAM offers the potential to bringing biopharmaceuticals a significant step closer to small molecule drugs that are defined rather than “characterized”.  Below are some of the current analytical technologies that MAM has the potential to replace in product development and QC:

·         SDS-PAGE and cSDS

·         Existing methods for glycan analysis

·         Various methods used to assay for purity

·         ELISAs used for HCP quantitation

·         Various identity tests

·         Methods used to quantitate charge variants

The economic drivers to move forward with MAM include:

·         Cost savings from reduced QC testing

·         Improved quality from using a test that tells us more about our product

·         The ability to retrospectively expand analysis by pulling up older data

It would be remiss to overlook a couple of hurdles MAM still needs to overcome comprehending that there are no significant technical barriers:

·         Establishing a history of method and instrument robustness

·         Worldwide regulatory acceptance and implementation

Additional implications of MAM implementation include:

·         Smaller QC staffing/footprint

·         Fewer instruments required for product development and QC testing

·         A shift in needed analytical skill-sets

All industries that encounter a fundamental change in “business as usual” corresponding to a substantial increase in efficiency are challenged by changing business practices, finding people familiar with the innovative technology and the displacement of people and companies.  While large biopharmaceutical companies have systems in place to plan around the eventual implementation of MAM and the impact on lab footprint, changing technical needs, and cost to doing business,  how are peripheral and smaller companies situated in preparing for the changes that will come about as MAM is implemented?  Some examples of potential changes include:


·         Reduced need for instruments and reagents for technologies to be replaced

·         How does the contract industry that the biopharmaceutical industry is dependent on adjust to the change?  Have these industries yet considered how to establish this new technology?

·         When is it prudent for smaller biopharmaceutical companies to embrace MAM?  The need of smaller companies and their dependence on contract companies will require an evolution of their interdependence that will be an interesting story to watch

·         Maintaining older methods and the companies required to support those methods until the analytical life cycle catches up with MAM

Currently MAM is slowly being implemented by large, biopharmaceutical companies with drivers including government agencies, business leaders, and vendors heavily investing in this technology.  It seems likely that MAM will be embraced first by large biopharmaceutical companies and leading regulators followed by smaller companies and world-wide regulatory acceptance.  A seminal event in this story will be when any major regulatory group requires implementation of MAM based on safety/quality desires.


Note:  To read the full article in IPQ requires a subscription to this journal.  I recommend that people and groups look through the free IPQ online content at and consider subscribing to the contents.

Modernizing USP Organic Impurities Standards
8/3/2017 4:12:58 PM

USP Expert Panel on Modernization of Organic Impurities Testing in Drug Substances and Drug Products is in the process of modernizing the USP chapters on organic impurities.  The panel is in the process of revising USP General Chapter <1086>.  The revisions align the USP chapter with current regulatory guidelines for over-the-counter and for generic products, which also references General Chapter <466> Ordinary Impurities and General Notices 5.60.  Revisions also harmonize terminology and principles with ICH Q3A and Q3B.  The Expert Panel is also creating a new mandatory chapter, <476> Organic Impurities in Drug Substances and Drug Products, including acceptance criteria aligned with the organic impurity thresholds established in ICH guidelines.  Chapter <476> will support those monographs that do not include specific impurity tests and those monographs that need additional guidance.

A workshop in September 2011, co-sponsored by USP and FDA on over-the-counter drugs and a survey by USP in June 2013 of current stakeholders led to the creation of an Expert Panel charged with the revision of <1086> (informative chapter) and the development of a new chapter <476> (mandatory chapter).  A Stimuli article, in-process revisions of the general chapter <1086> and the new chapter <476> were published in the Pharmacopeial Forum 40(3).  Revised drafts of the two chapters consolidating public comments were published in Pharmacopeial Forum 41(3). Now, a set of revised drafts will be published in an upcoming version of Pharmacopeial Forum.  Watch for drafts to be published by year end 2017.

Key Contacts:

Antonio Hernandez-Cardoso, Senior Scientific Liaison, USP

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