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June 16, 2020

CMC Enterprise Pharmacy – 608036 – 06/04/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Eugene A. Woods Recipient Title President and Chief Executive Officer CMC Enterprise Pharmacy 1000 Blythe BoulevardCharlotte, […]
June 16, 2020

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin(ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer […]
June 16, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 15, 2020

For Immediate Release: June 15, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 15, 2020

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

For Immediate Release: June 15, 2020 Today, the U.S. Food and Drug Administration is warning health care providers about a newly discovered potential drug interaction related […]
June 15, 2020

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

For Immediate Release: June 15, 2020 Today, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and […]
June 15, 2020

Generic Drug User Fee Amendments

What are the fee facility fee types under GDUFA II? There are three types of facility fees: (1) an active pharmaceutical ingredient (API) facility fee; (2) […]
June 15, 2020

Generic Drugs Program Activities Report – Monthly Performance

GDUFA YEAR/Actions This Month 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020 Refuse to Receive (RTR) – Originals 1 3 4 […]
June 15, 2020

Compounding Quality Center of Excellence Virtual Conference: Working Together for Patient Safety – 09/21/2020 – 09/22/2020

Date: September 21-22, 2020 Location:The web link to the virtual conference will be sent via email to participants a few days prior to the conference. About […]
June 15, 2020

Duy Drugs Inc. – 542933 – 05/27/2020

Delivery Method: Electronic Mail Reference #: 20-HAFE4-WLCOL-12 Product: Dietary SupplementsDrugs Recipient: Recipient Name Mr. Ricardo Mayo-Alvarez Recipient Title President/Owner Duy Drugs Inc. 1730 NW 79th Ave.Doral, […]
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