The Lachman Blog

23
Apr

Lachman Consultants COVID-19 Survey Results

From March 31 through April 14, 2020, Lachman Consultant Services, Inc. (Lachman Consultants) conducted a voluntary survey of professionals working in the pharmaceutical, biotechnology, medical device and other sectors related to the greater life sciences industry. The purpose of the survey was to take a “pulse” of the overall organizational and industry impact of the […]

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22
Apr
Lightning strike from a thunderstorm

Jump in Number of Clinical Trials for COVID 19 Treatments Explodes

In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]

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21
Apr

CBD Products – As FDA Resources are focused on COVID-19, will it be this virus that prompts FDA to regulate this Industry?

CBD products are available just about everywhere – you see them show up in gas stations, supermarkets, the internet, convenience stores, farm markets, and just about any place where things are sold.  CBD appears in drinks, pastry, candy, as an oil, and is infused in just about anything that can be orally ingested, or in […]

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21
Apr

Sci-Fi to Reality!

Science fiction has always been the white board for technological innovation.  Think of all the books and/or movies you have digested.  How many times have you said, “well, that will never happen?” And looking back, how many futuristic concepts have eventually become reality?  More than you may realize. Let me give you a few fun […]

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20
Apr

All Hands-On Deck – Pharmacy Compounding for Hospitals of Certain Drugs Approved in a Pinch

Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]

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20
Apr
Capsules in mortar

Emergency Preparedness – FDA Continues Active Oversight in the Compounding Space

FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]

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17
Apr

MAPP 5200.7 Rev. 1 Issued Regarding Filing Review for Certain Amendments and Supplements

FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review. Just a reminder that a MAPP is a document that provides a transparent view into how the […]

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17
Apr

Another Histamine H2 Receptor Antagonist Implicated in the NDMA Impurity Saga

The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]

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16
Apr

Day One OGD Generic Drug Forum, Some Statistics

Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program.  There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic […]

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