EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Are You ‘Qualified’ under the Preventative Controls for Human Food Rule?
Who is “qualified” under FDA’s final rule on preventive controls for human food? Why would someone want to be “qualified?” What is the role of someone who is “qualified?” How much of a role does a “qualified” person play to ensure a safe and wholesome food supply? The Preventative Controls for...
FSMA Final Rule on Sanitary Transportation of Food Includes Major Revisions
FDA released the FSMA Final Rule on Sanitary Transportation of Human and Animal Food on April 6, 2016. The final rule, which is part of the agency’s implementation of the 2005 Sanitary Food Transportation Act, contains some significant revisions of the proposed version, including affirming that...
What Makes a Good Sampling Plan?
By EAS Senior Consultant William R. Fairweather, PhD. You have a question, so you design a study to explore it. You determine that A is better than B and that the average difference is 3 units. It should be obvious that this is not sufficient information, but why not? After all, it is exactly what...
Implementing FSMA for Imports is FDA’s Biggest Challenge
FDA hosted an excellent day-long public meeting on March 21, 2016 to review the import-related elements of the new FSMA regulations. In opening remarks, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor noted that implementing import provisions is the agency’s biggest FSMA...
The Purpose of a DEA Regulatory Investigation
By EAS Senior Consultant Karen Famiglietti Everyone has read recent newspaper and internet stories about the rise in heroin abuse and its relationship with pharmaceutical opiates that were originally prescribed for legitimate medical reasons. Unfortunately, this problem has been around since the...
FSMA and Third-Party Auditing
A key piece of the regulatory jigsaw puzzle as FDA moves ahead with implementing the Food Safety Modernization Act (FSMA) is the voluntary, user-fee based program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities and issue food and...
What Are Medical Foods (and What They are Not)
By Jeanne Hoskin, Ph.D., EAS Senior Consultant Prior to 1972 medical foods were regulated as prescription drugs under section 201(g)(1)(B) of the FD&C Act, requiring manufacturers to conduct drug trials and submit Investigational New Drug license applications and New Drug Applications. It was...
Produce Final Rule Goes into Effect
The Food Safety Modernization Act (FSMA) extended FDA’s authority to include produce all the way to the farm level, which put the agency in unfamiliar regulatory territory. To avoid burdening covered facilities with unreasonable compliance demands, the agency proceeded with due caution in...
Getting to Grips with the electronic Common Technical Document (eCTD) Process
By Albert Yehaskel Completing a successful electronic Common Technical Document (eCTD) submission can be daunting, even with the help of guidance documents from the International Conference on Harmonization (ICH) – which developed the eCTD – or from the Food and Drug Administration....
FSMA Implementation Enters a New Phase
The Food and Drug Administration hosted a public meeting in Chicago on October 20, 2015 to discuss the recently released final rules on preventive controls for human and animal food, along with plans for the next phase of FSMA implementation. This was a substantive meeting and I encourage you to...
New Drug Development in the 21st Century
By Nancy Chew Most people who work in the pharmaceutical industry know that drug development comprises of pharmaceutical development, animal pharmacology and toxicology studies, and clinical research; many also know that there are quality standards applied to manufacturing and controls that...
Managing FDA Inspections
With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in the direction that you help set. To provide you with that knowledge, this webinar will cover:
Preparing for FDA Foreign Drug Inspection
By EAS Senior Consultant Robert C. Fish An FDA drug inspection can be a very stressful experience. If it is a pre-approval inspection there is a lot at stake concerning the outcome. If the company does not pass, the application (NDA/ANDA) may not be approved or the approval may be significantly...
FDA Revises Definition of “Qualified Auditor” in the Preventive Controls Rule
The Food and Drug Administration released two key FSMA-mandated regulations last month -- a final rule on current good manufacturing practices (CGMPs) and risk-based preventive controls for food for humans and a related final rule on food for animals. The rules were released on September 10 and...
When Should a Drug Compounder Register as an Outsourcing Facility?
By EAS Senior Consultants Len Valenti and Douglass Oeller When is it appropriate for a compounding pharmacy to register as an outsourcing facility under 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)? The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013,...
A FSMA Milestone
As I prepare this FSMA Perspective article, we are anticipating a significant milestone in the implementation of FSMA's preventive control philosophy – release of a final rule on current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and a...
FDA’s New Medical Device Regulations
By EAS Senior Consultant Kevin Walls The Food and Drug Administration has recently implemented two new rules that affect all medical device manufacturers, initial distributors and repackager/relabelers. The first new rule that went into effect on September 24, 2014, but up until now affected fewer...
FDA Seeks Input on Proposed User Fees for Accreditation of Third-Party Auditors
The Food Safety Modernization Act requires the Food and Drug Administration to establish an accreditation program to strengthen foreign food safety audits. The agency issued a proposed rule for an accreditation program on July 29, 2013. In a related July 24, 2015 notice, the agency released a...
FDA Invites Comment on Draft Mandatory Recall Guidance
The Food and Drug Administration issued draft guidance on mandatory recalls in a May 7, 2015 Federal Register notice and is inviting public comment by July 6. The draft document presents the agency’s current thinking on how the food industry can implement the mandatory food recall provisions the...
Corporate Culture Meets FSMA Compliance at the Intersection of Food Safety
By Amy Scanlin, M.S., EAS Consulting Group, LLC When the FDA’s overhaul of food safety, the Food Safety Modernization Act (FSMA), is fully rolled out in 2016 it will be the largest change the U.S. food industry has seen. And yet with all the increased requirements for compliance there is one link...
When the FDA Inspector Wants to Take Photographs
By EAS Senior Consultant Joseph Famiglietti Managing an FDA inspection is in itself a difficult task, but what should you do when an FDA investigator wants to take photographs at your facility? Whether it is pest sightings, equipment issues, or poor employee practices, the investigator has been...
FDA Briefs Stakeholders at FSMA Public Meeting
FDA officials discussed their “work in progress” toward implementing the Food Safety Modernization Act at a public meeting hosted by the agency in Washington, D.C. April 23-24, 2015. The agency is currently considering some new inspection ideas, they explained. For example, they may...
Welcome to Europe!
By EAS Senior Consultant Sue Oldreive You say color, I say colour. You say "dietary supplement", we, legally, say "food supplement." And of course, the French say "complément alimentaire," the Danish say "Kosttilskud" and the Italians say "Supplemento Alimentare." With 27 different Member States...
Budgeting for FSMA Implementation
Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency's Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4. Mindful of pressures on the federal budget, the...
With FSMA in Mind, GAO Reviews FDA’s Overseas Offices
FDA needs to adequately staff its foreign offices – where 44 percent of positions were vacant as of October 2014 -- to fulfill its inspection mandate under the Food Safety Modernization Act (FSMA), according to a newly released report by the Government Accountability Office (GAO). Under FSMA, FDA...
Verifying Label Claims “By Input” Unacceptable
By EAS Senior Consultant Tara Lin Couch, Ph.D. The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet...
Commenters Say Re-proposed FSMA Animal Food Rule Needs Further Revision
The December 15 comment deadline on FDA’s re-proposed rule on Preventive Controls for Animal Food has come and gone. Stakeholders generally welcomed the supplemental proposal as an improvement on the original proposed rule. But further significant changes are needed, according to recent...
FDA’s Generic Drug User Fee Act (GDUFA) – Drug Master Files (DMFs)
By Charles “Chris” Celeste, Director of Regulatory Information and Submissions Two years have passed since passage of the Generic Drug User Fee Act (GDUFA). GDUFA is a significant law that introduced new requirements for active pharmaceutical ingredient (API) manufacturers, including fees...
The Importance of Food Recall Readiness
By EAS Senior Consultant Dan Okenu, Ph.D. Product recalls are a fact of life in the food industry. Recalls occurred an average of 12 times per week. Allergens remain the largest cause of recalls, due to mislabeling, cross-contamination or being undeclared. Large recalls of peanut products, eggs,...
Revised FSMA Proposed Rules Address Stakeholder Concerns
The Food and Drug Administration’s supplemental texts for four proposed rules that would implement provisions of the Food Safety Modernization Act (FSMA), published September 29 in the Federal Register, address numerous concerns raised by stakeholders. The agency, for example, changed its...