FDA Archives - Page 40 of 46 - Lachman Consultant Services, Inc.

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

By Linda Evans O'Connor 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, […]

May

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

By Bob Pollock 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 […]

Apr

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

By Bob Pollock 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 […]

Apr

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

By Pete Manger 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 […]

Apr

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

By Linda Evans O'Connor 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 […]

Apr

Lachman COVID-19 Survey Provides Interesting Insights

By Linda Evans O'Connor 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 […]

Apr

With Nine Reporting Days Left in April, OGD Approval Actions Respectable

By Bob Pollock Apr 21, 2020 ANDAs Approvals FDA Regulatory Affairs

Through April 19 (and one action for the 20th) reporting on the FDA all Approvals list (here) tallies 37 full approval actions and 16 tentative approval actions for a total of 53 approval actions. The month started out very strong and, if the rate of approvals continues through the end of the month, OGD might […]

Apr

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

By Bob Pollock Apr 21, 2020 CBD Dietary Supplements FDA Regulatory Affairs Unapproved Drugs

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 […]

Apr

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

By Bob Pollock Apr 20, 2020 Compounding COVID-19 FDA Regulatory Affairs

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 […]

Apr

Another Histamine H2 Receptor Antagonist Implicated in the NDMA Impurity Saga

By Bob Pollock Apr 17, 2020 ANDAs Compliance FDA NDA Regulatory Affairs Science & Technology

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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FDA

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

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

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

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

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

Lachman COVID-19 Survey Provides Interesting Insights

With Nine Reporting Days Left in April, OGD Approval Actions Respectable

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

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

Another Histamine H2 Receptor Antagonist Implicated in the NDMA Impurity Saga

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