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July 11, 2020

FDA Updates on Hand Sanitizers with Methanol

4E Global, SAPI de CV (Mexico) 07/08/2020 Blumen Clear Advanced Hand Sanitizer with 70% Alcohol Not listed FDA tested product; contains methanol; FDA recommended a recall […]
July 10, 2020

Pharmaceutical Quality Resources

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER established the Office of […]
July 10, 2020

Cancer Clinical Trial Eligibility Criteria: Brain Metastases

Docket Number: FDA-2019-D-0357 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Draft published:  […]
July 10, 2020

Center for New Medicine/Perfectly Healthy by Connealy MD – 605804 – 07/06/2020

Product: Dietary SupplementsDrugs Recipient: Recipient Name Dr. Leigh Erin Connealy Center for New Medicine/Perfectly Healthy by Connealy MD 6 Hughes, Suite 100Irvine, CA 92618United States Issuing […]
July 10, 2020

Option Care Enterprises – 538040 – 07/01/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name John C. Rademacher Recipient Title President and CEO Option Care Enterprises 3000 Lakeside DriveSuite 300NBannockburn, IL […]
July 10, 2020

Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies

Docket Number: FDA-2019-D-0359 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research [Draft published […]
July 10, 2020

Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients

Docket Number: FDA-2019-D-0358 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research [Draft published […]
July 10, 2020

Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections

Docket Number: FDA-2019-D-0363 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research [Draft published […]
July 9, 2020

Coronavirus (COVID-19) Update: Daily Roundup July 9, 2020

For Immediate Release: July 09, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
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