29
Apr

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

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

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

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

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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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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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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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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16
Apr
Countdown numbers flip counter. Vector isolated 0 to 9 retro style flip clock or scoreboard mechanical numbers set black on white

March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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