PROGRAM INCLUDES THE REVIEW OF NON-STERILE PRODUCTS John W. Metcalfe, Ph.D., of the New Drug Microbiology Staff at CDER gave an excellent, informative presentation on “Regulatory Review Perspectives for Non-Sterile Drug Products” at the PDA Global Microbiology Conference on Monday, October 21, 2013 in Bethesda, MD. This presentation presented information on a Pilot Program … [Read more...]
FDA’S CDER SUMMARIZES TOP TEN 483 OBSERVATIONS AT PDA/FDA MEETING IN BALTIMORE (9/12)
COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. At this year's PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date. The Observations within the top ten usually do not change --- although their frequency may vary. Where a specific section is indicated, the Title indicates … [Read more...]
“FDA’S CONTRIBUTION TO THE DRUG SHORTAGE CRISIS” — A HOUSE OF REPRESENTATIVES STAFF REPORT (6/15/12)
The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA. Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response. Enclosed below are several of the key … [Read more...]
IMPORT ALERT FINDING GREATER USAGE WITHIN FDA’S BAG OF “WEAPONS”
GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C.V. (03/9/12) ALL RECEIVE IMPORT ALERTS WITHIN ONE MONTH AS PART OF THEIR WARNING LETTERS The FDA has recently begun to use within their CDER Warning Letters the following terminology on a frequent basis. This includes … [Read more...]
CDER GUIDANCES 2011– NEW/REVISED/WITHDRAWN
During 2011 CDER released a number of new Guidance for Industry documents. Many of these documents are quite difficult to locate within knowing the exact name of the document. These documents include the very widely publicized Process Validation (January 2011), several relating to PET (Positron Emission Tomography) products and their approvals, as well … [Read more...]
