Regulatory Affairs

07
Apr

Regulatory Intelligence

How do companies keep up with the rapidly changing world of drug and device regulations?  Some companies have entire departments dedicated to these efforts.  Other companies have people doing it part-time, perhaps as an add-on to their primary jobs.  Some companies may not pay attention at all. Lachman offers a solution to this.  We develop […]

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07
Apr

In Case You Did Not Know – Lachman Consultants Offers Remote Training Options

Training of employees remains a hallmark of the industry’s ability to deliver high quality medicines, devices, and diagnostics.  Training is a crucial activity, now, more than ever, in this rapidly changing environment. During this period of social distancing, when the experts cannot travel to your site to perform training, that does not mean that this […]

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06
Apr
Woman with face protective mask

Let’s Face It! Protective Masks Have Revised Enforcement Policy Issued by CDRH

The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here).  The CDRH says the relaxed policy will remain in effect […]

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03
Apr

COVID-19 Devices in the Fast Lane – Help is Here!

Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts.  Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies.  While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront.  We want to assure you that Lachman […]

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01
Apr

CTAP Program to Accelerate COVID-19 Drug Development and Approval

  Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”  The FDA will continue to enhance this emergency program to bring safe […]

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31
Mar
Caution Tape

FDA Promotes Hydroxychloroquine to Category 1 Status for Compounders – Wait a Minute!

My eyes almost popped out of my head when I read this article (here) concerning FDA’s move to place hydroxychloroquine in Category 1 for use by compounders based on a potential drug shortage created mostly by the administration’s hope that the drug may have some effect on COVID 19.  It is one thing to use […]

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30
Mar

FDA Continues to Expedite Diagnostic Tests to Detect COVID 19

The FDA announcement (here) of its activities involved in expediting diagnostic tests for the Corona Virus (COVID 19) explains the actions that FDA has taken in response to this public health emergency. “The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the […]

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