The Lachman Blog

01
Sep
Slippery Slope road sign in front of cloudy sky background

EUA for Vaccine – Slippery Slope or a Shot in the Dark

The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests.  By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]

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25
Aug

Lachman Consultants Participates in Webinar with Arnold & Porter on DSCSA

Earlier this month, Ricki Chase, Executive Director, participated as a presenter in the webinar “Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies” in collaboration with Howard Sklamberg (Partner) and Abraham Gitterman (Senior Associate) of Arnold & Porter. In this webinar, the following was covered: The basics of the Drug Supply Chain Security […]

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24
Aug

After Some Missteps on EUAs, FDA’s Action on Convalescent Plasma Has the Science Behind It

Clearly, the FDA has acted too early on Emergency Use Authorizations (EUAs) for a few COVID-19 tests and products.  The flurry of revocations of EUAs for tests that were deemed not reliable have cause a sputter in the onset of testing ramp up.  Another specific example was the FDA’s EUA for hydroxychloroquine, which left many […]

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14
Aug
Police Officer Making Traffic Stop

Do You Have Your Checkbook Ready? Be sure Clinicaltrials.gov Listings Are Made and Are Accurate!

FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018.  The FR Notice announcing the availability of the guidance (here) indicates […]

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13
Aug
Starting block athletes

Are You Ready? Because the FDA IS Getting Ready!

How has COVID 19 changed your organization?  Do you have fewer or newer employees?  Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving?  Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA?  […]

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12
Aug

Analytical Data Review:  The Thankless Job

In any analytical laboratory that performs cGMP testing, data review is required.  However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore.  The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation.  The role of the data reviewer is to […]

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