Biologics

12
Nov

Mission Critical Inspections, What About Me?  What’s a Body to Do?

Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections.  Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]

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11
Nov

Day Three at AAM’s GRx-Biosims Virtual Conference – Some Insights

Well, here we are, at the end of the conference already.  Let us look at highlights of the Day 3 activities. Dr. Alex Azar, Secretary of Health and Human Services, gave the opening keynote address and, in usual fashion, he thanked the generics and biosimilar industries for making high-quality generic drugs and biosimilars available to […]

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21
Sep

FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass.  Released this morning the FDA’s web page (here) asks in its opening line […]

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14
Sep

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 […]

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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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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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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 […]

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26
May

New Recommended PDE Limits for Three Solvents Proposed by ICH

Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).”  The recommendations are based on the testing parameters established for developing permitted […]

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27
Apr

FDA Launches Webpage on COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here.  Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]

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