CDER

CDER
Share

CDER

 •  September 19

The Compounding Quality Act On November 27, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. Title I of the DQSA was the Compounding Quality Act (CQA) which provides for additional FDA oversight of compounding pharmacies. CQA created a new entity known as an outsourcing facility under Section 503B of the Food, Drug, and...

CDER

 •  September 15

Slide 1 Hello. I’m Marianne Noone with the FDA’s Center for Drug Evaluation and Research, also known as CDER. In this module, I’ll explain the biomarker qualification process and discuss the submission roadmap for biomarker qualification requesters. Slide 2 The Biomarker Qualification Program was established to encourage the development of...

CDER

 •  September 8

On September 5, 2017, FDA issued a warning letter to a Meridian Medical Technologies facility, located in Brentwood, Missouri, which manufactures Mylan’s EpiPen (epinephrine injection). The warning letter identifies significant violations of current good manufacturing practice (CGMP) requirements for its epinephrine auto injectors, including EpiPen...

CDER

 •  September 7

The potential for biotechnology to transform medicine remains immense, with several therapeutic protein products already having come into widespread clinical use and hundreds of proteins under clinical investigation. For the FDA, the regulatory oversight of therapeutic protein development poses a great challenge, not only because of the increasing...

CDER

 •  September 6

Announcement Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with...

CDER

 •  August 31

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the...

CDER

 •  August 30

Announcement Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date,...

CDER

 •  August 22

Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the...

CDER

 •  August 10

[08/10/2017] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. Health care professionals and patients...

CDER

 •  August 8

CDC lab testing detects product contamination, links products to patient infections [8/8/2017] FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia,...