FDA

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12
May

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

By    May 12, 2020    FDA FDA Uncategorized

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

By    May 11, 2020    Compliance FDA Generics New Drugs Regulatory Affairs

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

By    May 08, 2020    Compliance Contract Manufacturers COVID-19 Drugs Enforcement FDA Manufacturing Quality

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

By    May 06, 2020    FDA FDA Uncategorized

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

By    May 04, 2020    COVID-19 FDA Fraud Regulatory Affairs

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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29
Apr

BE Studies and COVID 19 Pandemic – What’s an Applicant To Do?

By    Apr 29, 2020    Bioequivalence FDA Generics Regulatory Affairs

Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies.  The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]

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29
Apr

Jam the Scammers – A Group of White Hats Step Up – and You Can’t Even See Them at Work

By    Apr 29, 2020    Cybersecurity FDA Regulatory Affairs

With a sense of honor and the common good, last month some scammers “promised to refrain” from attacking healthcare operations during the COVID-19 pandemic.  Unfortunately, some people believed them! I get it.  This virus impacts every one of us.  We all would like to believe that, in this current environment, people will step up and […]

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27
Apr

Lachman Consultants New Webinar Series Provides Timely and Valuable Information To The Pharmaceutical Industry

By    Apr 27, 2020    FDA FDA

Lachman Consultant Services, Inc. (Lachman Consultants) is helping you to navigate the ever-changing economic and business environment with our new webinar series. During these times of social distancing and working remotely from home, these webinars are Lachman Consultants latest way of providing you with up-to-the-minute, valuable information to about a wide range of topics that […]

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27
Apr

Lachman COVID-19 Survey Provides Interesting Insights

By    Apr 27, 2020    Biologics Compliance FDA Medical Devices New Drugs Pharmaceutical industry Science & Technology

Lachman Consultants recently conducted a survey of professionals working in the pharmaceutical, biotechnology, medical device, and other regulated sectors related to the greater life sciences industry with the goal of taking the “pulse” of the overall organizational and industry impact of the COVID-19 pandemic. The results of the survey can be found here. A few […]

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