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Division of Drug Marketing Advertising and Communications FDA Pharmacy Student Experiential Program

FDADocs 5/12/2008 | 0 (0) | 22 | 1 | 0 | English

The Division of Drug Marketing, Advertising, and Communications (DDMAC) protects the public health by assuring prescription drug information is truthful, balanced, and accurately c...  ... more>>

FDA in the International Community CDER Forum for International Drug Regulatory Authorities

FDADocs 5/9/2008 | 0 (0) | 16 | 1 | 0 | English

CDER Forum for International Drug Regulatory AuthoritiesApril 16 ??? 20, 2007CDER???s International ProgramJustina A. Molzon, M.S. Pharm., J.D. Associate Director for Inter...  ... more>>

Embryonic Stem Cell based Therapies US FDA Regulatory Expectations

FDADocs 5/5/2008 | 0 (0) | 19 | 1 | 0 | English

Embryonic Stem Cell-based Therapies: US-FDA Regulatory ExpectationsDonald W. Fink, Jr., Ph.D.Phone: (301) 827-5153 E-Mail: donald.fink@fda.hhs.govOffice of Cellular, Tissue and Gene Therapies  ... more>>

Hospital Acquired Pneumonia HAP IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 36 | 1 | 0 | English

Hospital Acquired Pneumonia (HAP) Joint FDA/IDSA/PhRMA WorkshopSary Beidas, MD Medical Officer CDER/DSPIDPNovember 20, 2002Definition of HAP (& Diagnosis):???Clinical: Temp, WBC, Sputum  ... more>>

Drug and Device Product Approvals FDA Drug and Device Product Approvals

FDADocs 5/9/2008 | 0 (0) | 47 | 1 | 0 | English

FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 17 (1) January 1994Center for Drug Evaluation and Research *George R. Scott (301) 443-3910 Center for Biologics Evaluation and Research Joseph  ... more>>

FCG FDA SPL Demo Conference Meeting and Workshop Presentations by CDER Staff

FDADocs 5/12/2008 | 0 (0) | 26 | 1 | 0 | English

SPL DemonstrationJune 4, 2004Who is FCG?Who is FCG?A leading provider of consulting, technology, applied research and outsourcing services to the life sciences and he...  ... more>>

Antimicrobial Drug Development for Acute Bacterial Meningitis IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 40 | 1 | 0 | English

Antimicrobial Drug Development for Acute Bacterial MeningitisJoint FDA/IDSA/PhRMA WorkshopImo Ibia, MD, MPH Medical Officer FDA/CDER/DSPIDPNovember 20, 2002Office of New Drugs IV Center  ... more>>

FORM FDA RECALL AUDIT CHECK REPORT

FDADocs 5/9/2008 | 0 (0) | 51 | 0 | 0 | English

1. RECALL INFORMATION a. RECALL NUMBER b. RECALLING ESTABLISHMENT2. PROGRAM DATA (CHECK BOX IF PREVIOUSLY SUBMITTED) (DO NOT COMPLETE IF REPORTED UNDER FDA 2123) a. ACCOMP DISTRICT CODE b. HOME  ... more>>

Recall Alert Information

FDADocs 5/9/2008 | 0 (0) | 74 | 0 | 0 | English

Attachment A ??? Recall Alert Information Submit the information listed below to the CRU and OE/DCMO via RES: ??? Product(s) Description ??? Codes ??? Recalling Firm ??? Short Reason for Recall  ... more>>

Pedigree Dog Food Recall

stiletto 8/13/2008 | 0 (0) | 4003 | 0 | 0 | English

FRANKLIN, Tenn. – August 08, 2008 – Mars Petcare US today announced a voluntary recall of limited bags of PEDIGREE® Complete Nutrition Small Crunchy Bites sold in Albertsons stores in Southern California and Las Vegas, Nevada. The pet food is being voluntarily recalled because of potential contamination with Salmonella. There have been no complaints or reports of injury resulting from consumption or handling of the recalled product.  ... more>>

Requested recall shellhigh

GovernmentDocs 5/5/2008 | 0 (0) | 44 | 0 | 0 | English

07083 Dear Dr. Gabbay:- 2 2007FDA requests that Shelhigh, Inc. initiate an immediate recall of all devices manufactured by your firm in Union, New Jersey. The products to recall include: Shelhigh  ... more>>

Recommendation for Recall Classification

FDADocs 5/9/2008 | 0 (0) | 58 | 0 | 0 | English

Attachment B - Recommendation for Recall Classification Update and transmit the electronic record in RES with the required information necessary for the CRU to review and classify the recall. RES  ... more>>

Hearltland recall notice

GovernmentDocs 5/4/2008 | 0 (0) | 52 | 0 | 0 | English

URGENT: DRUG RECALLHRS Lot All lot numbers beginning with the letter ???K??? Example K... lot number beginning with ???K???. The specific products and lot numbers subject to this recall can  ... more>>


   
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