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Recent FDA Links
- Presentation:
Coming of Age of Personalized Medicine (PDF - 797KB)
(5/22/2013)
-
Preventing Surgical Fires: Initiative Partners (updated
5/22/2013)
- MedWatch Safety Alert:
Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall -
Particulate Matter In Vials (Posted: 5/21/2013)
-
Potential “universal” influenza vaccine developed and tested at FDA
(Posted: 5/21/2013)
- MedWatch Safety Alert:
All Sterile Drug Products Made and Distributed By NuVision Pharmacy
Dallas Facility: Recall - Lack Of Sterility Assurance
(5/20/13)
- Presentations (5/17/13):
-
Challenges of Globalization (PDF - 834KB)
-
Adverse Event Reporting and Medication
Safety Considerations: A View from CDER’s Office of Surveillance and
Epidemiology (PDF - 445KB)
-
FDA Perspective: Transformational
Initiatives (PDF - 252KB)
-
The Regulatory Pathway for Rare Diseases
Lessons Learned from Examples of Clinical Study Designs for Small
Populations (PDF - 832KB)
-
The Value of A Qualified Outcome Measure
(PDF - 41KB)
- Spanish Drug Safety Communication:
Zolpidem: La FDA aprueba cambios de etiqueta para los
productos con zolpidem, que incluyen nueva dosificación y una
recomendación de evitar conducir el día posterior al uso de Ambien CR
(5/17/13)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Reviews (FDASIA)
(Updated: 5/16/13)
-
Medication Guides
(Updated: 5/16/13)
-
Potential Signals of Serious Risks/New Safety Information
Identified from the FDA Adverse Event Reporting System (FAERS)
(Updated: 5/16/13)
-
Public Workshop: Fecal Microbiota for
Transplantation - Presentations (Posted: 5/16/2013)
-
Summary Basis for Regulatory Action, April 19,
2013 - SOLX® System (Posted: 5/16/2013)
-
A mouse model demonstrates a link between
transfused UVB irradiated platelets and acute lung injury
(Posted: 5/16/2013)
-
FDA Press Release:
FDA approves Simponi to treat ulcerative colitis
( 5/15/13)
-
Drug Firm Annual Registration Status
(Updated: 5/15/13)
-
Drug Firm Annual Registration Status Download File
(Updated: 5/15/13)
- FDA Drug Safety Podcast:
FDA approves label changes for zolpidem products,
including new dosing and a recommendation to avoid driving the day after
Ambien CR use (Updated:
5/15/13)
-
National Drug Code Directory (Updated:
5/15/13)
- FDA Press Release:
FDA approves Nymalize—first nimpdipine oral solution for use in certin
brain hemorrhage patients (5/14/2013)
-
2013 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory
Committee Updated: 5/14/13- added
4/17/13 transcripts and summary minutes (5/14/2013)
- Guidance for Industry:
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety
Studies Using Electronic Healthcare Data (PDF - 501KB) (5/13/2013)
- FDA Drug Safety Communication:
FDA approves label changes for zolpidem products, including new dosing
and a recommendation to avoid driving the day after Ambien CR use (5/13/2013)
-
Drug Safety Oversight Board Meeting, March 21, 2013, Public Summary
(5/13/2013)
-
Pediatric Exclusivity Statistics (updated 5/10/2013)
- FDA Public Workshop: Clinical
Trial Design Issues - Development of New Therapies for Non-Muscle
Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel,
Douglas Pavilion C & D, One Market Place, San Diego, CA.
Meeting information
(5/9/2013)
-
Paragraph IV Patent Certifications (updated 5/9/2013)
-
Requesting Speakers from CDER (5/9/2013)
-
Guidance for Industry: Implementation of an Acceptable Abbreviated Donor
History Questionnaire and Accompanying Materials for Use in Screening
Frequent Donors of Blood and Blood Components (Posted: 5/8/2013)
-
AABB Donor History Questionnaire Documents
(Posted: 5/8/2013)
- FDA Drug Safety Podcast:
Valproate Anti-seizure Products Contraindicated for Migraine Prevention
in Pregnant Women due to Decreased IQ Scores in Exposed Children
(Posted: 5/7/2013)
-
Current Drug Shortages Index (updated 5/7/2013)
-
CDER Director's Mailbag Question on Singulair (Posted: 5/7/2013)
- FDA Drug Safety Podcast:
FDA warns about potential medication errors resulting from confusion
regarding nonproprietary name for breast cancer drug Kadcyla
(ado-trastuzumab emtansine)
(Posted: 5/7/2013)
- Prescription Drug User Fee Act (PDUFA):
The
Dear Colleague Letter (PDF - 54KB), in anticipation of FY 2014
Invoices, was mailed Friday, 5/3/2013. Responses are due by 6/12/2013.
If you do not receive the letter by 5/31/2013, please contact Ashley
Jones or Beverly Friedman at 301-796-3602 (Posted: 5/7/2013)
- Manual of Policies and Procedures (MAPP)
5000.6R1
Office of
Pharmaceutical Science Coordinating Committee (OPS CC)
(PDF - 66KB)
(Posted: 5/7/2013)
-
FDA discovery that Ad5 vector uses coagulation
factor X to block complement proteins has major implications for gene
therapy (PDF - 182KB)
(Posted: 5/7/2013)
-
Expanded and improved approach to identifying
surface protein markers could support development of therapies with
human bone marrow multipotent stromal cells (PDF
- 262KB) (Posted: 5/7/2013)
- Drug Safety Communication:
FDA warns about potential medication errors resulting from confusion
regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab
emtansine) (Posted: 5/6/2013)
-
List of Establishments Granted Approval for a Variance to 21CFR640.3(d)
and 21CFR640.3(f) (Posted:
5/6/2013)
- Spanish Drug Safety Communication:
Medicamento anticonvulsivo Potiga (ezogabina) vinculado
con anomalías de la retina y decoloración azulada de la piel
(5/3/2013)
-
FDA Adverse Event Reporting System (FAERS): Latest
Quarterly Data Files (updated
5/2/2013)
-
FAERS Quarterly Data Files Documentation
(updated 5/2/2013)
-
National Drug Code Directory (updated
5/2/2013)
-
Submission of New Drug
Application/Abbreviated New Drug Application Field Alert Reports:
Notice of Form FDA 3331-Automated Pilot Program (Posted: 5/2/2013)
-
Public Workshop: Application of Advances in Nucleic Acid
and Protein-Based Detection Methods for Multiplex Detection of
Transfusion-Transmissible Agents and Blood Cell Antigens in Blood
Donations Transcripts - April 10, 2013 (PDF - 5.3MB)
(Posted: 5/2/2013)
-
Public Workshop: Application of Advances in Nucleic Acid
and Protein-Based Detection Methods for Multiplex Detection of
Transfusion-Transmissible Agents and Blood Cell Antigens in Blood
Donations Transcripts - April 11, 2013 (PDF - 6.1MB)
(Posted: 5/2/2013)
-
Notice to Industry: FDA Launches Pilot Project for Electronic
Submission of Field Alert Reports
(5/1/2013)
- FDA News Release:
FDA approves Plan B One-Step emergency contraceptive without a
prescription for women 15 years of age and older
(5/1/2013)
- FDA Drug Safety Podcast:
FDA limits duration and usage of Samsca (tolvaptan) due to possible
liver injury leading to organ transplant or death
(5/1/2013)
- Drug Safety Communication:
FDA limits duration and usage of Samsca (tolvaptan) due to possible
liver injury leading to organ transplant or death
(4/30/2013)
- MedWatch Safety Alert -
Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall -
Precipitation or Crystallization in IV Bag or IV Line Upon
Reconstitution
(4/30/2013)
-
Current Drug Shortages Index (updated
4/29/2013)
- Manual of Policies and Procedures
(MAPP)
6030.9 Good Review Practice: Good Review Management Principles and
Practices for Effective IND Development and Review(PDF - 297KB) (updated
4/29/2013)
-
ANDA Suitability Petition Reports (updated
4/26/2013)
-
First-Time Generic Drug Approvals - 2013 (updated
4/26/2013)
-
FDA study reinforces no safety concerns from residual formaldehyde in
some infant vaccines (Posted:
4/25/2013)
- Public Notification:
“Sex Plus” Contains Hidden Drug Ingredient
(4/25/2013)
- Public Notification:
“Zoom-Zooma-Zoom” Contains Hidden Drug Ingredient
(4/25/2013)
- Guidance for Industry:
Regulatory Classification of Pharmaceutical Co-Crystals
(PDF - 84KB)
(4/25/2013)
- MedWatch Safety Alert:
All Sterile Compounded Products by Nora Apothecary And Alternative
Therapies: Recall - Lack of Sterility Assurance
(4/24/2013)
- Guidance for Industry:
Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors (PDF - 608KB) (updated
4/23/2013)
- Manual of Policies and Procedures
(MAPP)
5015.3 Cover Form for the Technical Review of Drug Master
Files (DMFs) (PDF - 47KB) (updated
4/23/2013)
-
FDA announces voluntary nationwide recall by Balanced Solutions
Compounding Pharmacy
(4/22/2013)
- FDA Public Workshop: Clinical
Trial Design Issues - Development of New Therapies for Non-Muscle
Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel,
Douglas Pavilion C & D, One Market Place, San Diego, CA.
Meeting information
(4/17/2013)
- FDA Public Workshop: Clinical
Trial Design Issues - Drug & Device Development for Localized Prostate
Cancer, May 5, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C &
D, One Market Place, San Diego, CA.
Meeting information
(4/17/2013)
- Guidance for Industry:Non-Penicillin
Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
(PDF - 212KB)
(4/17/2013)
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