Generics

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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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 […]

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07
May

Fast on the Trigger COVID-19 Response for Shortage Drugs

Looking over the daily COVID-19 updates from the FDA (here), I noticed that the OGD had approved “two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.”  Glad to see that […]

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01
May
Warning sign

Black Box Warning Added to Singulair and Montelukast Generics Labeling

The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair).  A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]

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29
Apr

BE Studies and COVID 19 Pandemic – What’s an Applicant To Do?

Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies.  The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]

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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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