29
Sep

Virtual Inspections Bringing Needed Expertise Remotely

Since the start of the pandemic when travel was limited, Lachman Consultants has been performing inspections.  In fact, we have performed audits and inspections at the same rate as we did before the pandemic, only now, most of them are remote.  We have been at the forefront of implementing effective state-of-the-art solutions.  During this time, […]

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29
Sep

AAM Releases Its 2020 Savings Report

The Association for Accessible Medicines released its 2020 Generic Drugs and Biosimilars Access and Savings in the U.S. Report (here) yesterday, outlining the savings that these products brought to American consumers in 2019. “In 2019, according to data provided by IQVIA, U.S. savings from generic drugs added up to $313 billion—including $96 billion and $48.5 […]

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28
Sep
Youth League Batter

Watch the Inventory of CRLs in Your Court – Don’t be Blindsided, Be Mindful

Did you ever wonder about the FDA’s requirement than an applicant respond to a complete response letter (CRL) within one year of its issuance as provided for in the regulations at 21 CFR 314.110?  Under this regulation, “an applicant must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified […]

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24
Sep

Benzodiazepine Boxed Warning Update, a Harbinger of Things to Come?

In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products.  The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, […]

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16
Sep

Weight Loss Drug Voluntarily Withdrawn for Apparent Safety Reasons

The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively.  This announcement was made on the Federal Register’s […]

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14
Sep

Current Coronavirus Factoids

The FDA has been more than busy in its efforts to address the COVID-19 pandemic.  Here is an update as of September 11, 2020 regarding some of the statistics the FDA has presented. The FDA has: Authorized 247 tests under emergency use authorizations (EUAs), of these: 197 are molecular tests 46 are antibody tests 4 […]

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11
Sep

FDA Says We Got Your Backs, as Always!

In an opinion piece in USA Today (here), eight career executives at the FDA, Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research, Peter Marks, Director of the Center for Biologics Evaluation and Research, Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, Associate Commissioner for Regulatory […]

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