New Drugs


FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass.  Released this morning the FDA’s web page (here) asks in its opening line […]

Read More
Wolf howling to the moon

Domestic Priority Inspections to Restart on July 20 – With Conditions

FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020.  The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]

Read More
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 […]

Read More

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

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 […]

Read More
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
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 […]

Read More

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 […]

Read More
1 3 4 5 7