Regulatory Affairs

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 […]

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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 […]

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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 […]

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24
Jun

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

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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22
Jun
FDA Updates

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved.  The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]

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17
Jun

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

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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