Compliance

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.  […]

Read More
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 […]

Read More
15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

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 […]

Read More
08
Jun

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

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 […]

Read More
08
Jun

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

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 […]

Read More
22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

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 […]

Read More
14
May

Lachman OnCall™ GMP Teleconsulting for the Life Sciences

Need answers to your urgent life science questions? Lachman Consultant Services, Inc. (Lachman Consultants) has launched Lachman OnCallTM GMP Teleconsulting. It’s your opportunity to speak to our Subject Matter Experts (SMEs) regarding your questions as they occur. Whether you have questions about compliance or a complex scientific or technical issue, we’re here and ready to […]

Read More
11
May
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

IQVIA VP Discusses the Market – Including Factors Impacting Patient Compliance

We all know that the most expensive prescription is the one the patient does not take.  Certainly, there are several factors that impact the decision for a patient to fill a prescription.  Failure to comply with medication directions can also impact the health of the patient.  These failures to comply can lead to more expensive […]

Read More
08
May
Document Issued for Manufacturing Facility Information Image

Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

Read More
1 18 19 20 59