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August 28, 2020

FDA Rationale for Recognition Decision: Daptomycin

As of August 24, 2020, the FDA-revised breakpoints (BPs), also referred to as susceptibility test interpretive criteria (STIC) for daptomycin for Enterococcus faecalis (including vancomycin-susceptible and […]
August 28, 2020

PDUFA VI: Assessment of Combination Product Review Practices in PDUFA VI

Combination products are therapeutic and diagnostic products that contain two or more types of medical products as constituent parts: a drug and device, a drug and […]
August 28, 2020

Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol

Summary Company Announcement Date: August 14, 2020 FDA Publish Date: August 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1 propanol […]
August 26, 2020

Nanomateriales, Sa De CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol

Summary Company Announcement Date: August 26, 2020 FDA Publish Date: August 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1-propanol. Company […]
August 26, 2020

FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities

[8/26/2020] FDA recently became aware of nitrosamine impurities in certain samples of rifampin and rifapentine. These are antibacterial drugs used to treat tuberculosis; rifampin is also […]
August 26, 2020

Las alergias estacionales: ¿qué medicamento es el indicado para usted?

El conteo de polen se ha disparado hasta las nubes. Usted está estornudando, tiene comezón en los ojos y se siente muy mal. Las alergias estacionales […]
August 26, 2020

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert – Boxed Warning about Risk of Leg and Foot Amputations Removed

[Posted 08/26/2020] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: Based on FDA’s review of new data from three clinical trials, the boxed warning about amputation risk […]
August 26, 2020

Integrated Assessment of Marketing Applications Virtual Workshop – 10/30/2020 – 10/30/2020

On This Page Date: October 30, 2020 Time: 9:00 AM – 3:00 PM ET New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing […]
August 26, 2020

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

Submit Comments by 10/26/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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