Compliance

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08
Jul

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

By    Jul 08, 2020    Compliance Compounders Compounding Efficacy Safety

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, […]

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08
Jul

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

By    Jul 08, 2020    Compliance FDA Microbiology Regulatory Affairs Sterility assurance

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 […]

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25
Jun

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

By    Jun 25, 2020    Biologics Biosimilars Compliance Data Integrity Regulatory Affairs Uncategorized

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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24
Jun

Any Interest in Homeopathic Drugs? 34,341 Comments Suggests So!

By    Jun 24, 2020    Compliance FDA Homeopathic Drugs Regulatory Affairs

The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog.  The most recent post on this topic was on June 17, 2020 (here).  That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters.  […]

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17
Jun

FDA Appears to Be Signaling That They May Be Getting Closer to Regulating Homeopathic Drugs

By    Jun 17, 2020    Compliance FDA Homeopathic Drugs Regulatory Affairs

Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market.  In the release, the FDA announces that it issued Warning Letters to four […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

By    Jun 15, 2020    Compliance COVID-19 FDA Generics New Drugs Regulatory Affairs

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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08
Jun

Temporary Provisions for Prescription Drug Sample Delivery and Receipt during the COVID-19 Pandemic Public Health Emergency

By    Jun 08, 2020    Compliance Drug samples FDA PMDA Regulatory Affairs

The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here).  This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record […]

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08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

By    Jun 08, 2020    ANDAs BLA cGMPs Compliance Data Integrity DMFs FDA NDA Regulatory Affairs

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

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22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

By    May 22, 2020    Compliance Drugs FDA Medical Devices Science & Technology

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

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