The Lachman Blog

10
Jul
Wolf howling to the moon

Domestic Priority Inspections to Restart on July 20 – With Conditions

FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020.  The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]

Read More
10
Jul
RIP Headstone

PETN Dead for Good After Final DESI Hearing Decision and Exceptions Are Deemed Withdrawn

The story started in 1962 with the congressional passage of the Kefauver-Harris Amendments that added efficacy requirements for all new drug approvals.  For those products approved for safety only during the period from 1938 to 1962, an evaluation of efficacy of those products was undertaken in the Drug Efficacy Study Implementation (DESI) program.  The DESI […]

Read More
08
Jul

Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearth of Evidence for the Effectiveness & Safety of Compounded Bioidentical Hormone Therapy

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT).  A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

Read More
08
Jul

One Slip Can Really “Bug” You or Your Product, but Help is On the Way!

One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology.  Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]

Read More
29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

Read More
29
Jun

STILL TIME TO REGISTER FOR “REMOTE AND VIRTUAL INSPECTIONS DURING THE COVID-19 PANDEMIC: REGULATOR PERSPECTIVES”

Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]

Read More
25
Jun

Lachman OnCall™ GMP Teleconsulting – When you can’t wait to get going.

When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]

Read More
1 2 131