22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

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21
May

List of Firms That Have Removed COVID-19 Diagnostic Tests

Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs).  Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]

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12
May

Senate Hearing On COVID 19 and Yes, Fauci Did Testify

Drs. Anthony Fauci (National Institute of Allergy and Infectious Diseases, NIH), Robert Redfield (Director, CDC), Stephen Hahn (Commissioner, FDA), and Brett Giroir (Assistant Secretary for Health, HHS) testified this morning before the Senate Committee on Health, Education, Labor, and Pensions, chaired by Senator Lamar Alexander.  The goal of the hearing is to identify what went […]

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12
May

REMINDER: Lachman Consultants’ Latest Webinar Series Provides Valuable Tips for Responding to FDA Inspectional Observations

Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]

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11
May
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

IQVIA VP Discusses the Market – Including Factors Impacting Patient Compliance

We all know that the most expensive prescription is the one the patient does not take.  Certainly, there are several factors that impact the decision for a patient to fill a prescription.  Failure to comply with medication directions can also impact the health of the patient.  These failures to comply can lead to more expensive […]

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08
May
Document Issued for Manufacturing Facility Information Image

Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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06
May

Lachman Consultants’ Latest Webinar Series Provides Valuable Tips for Responding to FDA Inspectional Observations

Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]

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04
May

Silver Ain’t No Silver Bullet – It’s Fraud, Says DOJ

The FDA posted a Department of Justice press release discussing a temporary injunction against a Utah firm from selling and marketing silver products as a prevention and cure for the corona virus. The press release states “The Department of Justice will take swift action to protect consumers from those who would recklessly exploit this public […]

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