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Recent FDA Links
May 8, 2008
-
User
Fee Billable Products Approved Under Section 351 of the PHS Act
- Updated (Posted: 5/8/2008)
-
Paragraph IV Patent Certifications
(updated 5/8/2008)
May 7, 2008
-
Drugs@FDA Downloadable Data Files
(updated 5/7/2008)
May 6, 2008
- CDER Manual of Policies and Procedures (MaPPs)
4520.2R
Providing General Consumer Information on New Molecular Entities on
CDER’s Web Site (5/6/2008)
- DA/ISPE Co-sponsored
Event: Regulatory Perspectives on Hot Topics, Regulatory Trends,
and Observations (E07), June 4-5, Washington, DC.
Meeting information and registration
(5/6/2008)
- Pubic Workshop: Developing
Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety
Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7,
2008, Silver Spring, MD.
Federal Register Notice
(5/6/2008)
May 5, 2008
-
Pediatric Research Equity Act
of 2007 (PREA) (Posted: 5/5/2008)
- 51st Annual FDLI & FDA Conference -
3/26-27/2008 (Posted: 5/5/2008)
-
Vaccine Safety Team (PDF - 300 KB)
- Carmen M. Collazo, PhD
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Safety Surveillance for Licensed Biological Products at
FDA's Center for Biologics Evaluation & Research (PDF - 206 KB)
- Robert P. Wise, MD, MPH
-
CBER Safety Initiatives: Tissue Safety Team (PDF - 47
KB) - Ruth Solomon, MD
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Blood Safety Team (PDF - 26 KB)
- Jonathan C. Goldsmith, MD
-
Drug Safety Oversight Board Roster
(updated 5/2/2008)
-
Drug Safety Oversight Board Meeting, March 20,
2008 Public Summary (5/2/2008)
- The prescribing
information for Enbrel (etabercept) is revised to include a
boxed warning about infections.
MedWatch Safety Information (5/2/2008)
May 1, 2008
-
Withdrawal of
Albumin (Human) 5%, Talecris Biotherapeutics (Posted: 5/1/2008;
Withdrawal Date: 4/30/2008)
-
Workshop: HL7 SPL Working Group Electronic Drug
Registration and Listing Meeting - Webinar (Posted: 4/30/2008, Meeting Date: 5/15/2008)
- Guidance for Industry:
Comprehensive List of Guidance Documents (updated 5/1/2008)
- Guidance for Industry:
New/Revised/Withdrawn List for 2008 (updated 5/1/2008)
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes (updated 5/1/2008)
April 30, 2008
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Common Technical Document (CTD) Modules/Sections
Corresponding to Summary Data Tables in Bioequivalence Submissions to
ANDAs (updated
4/30/2008)
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Drugs@FDA Downloadable Data Files
(updated 4/30/2008)
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Postmarketing Study Commitments (updated
4/30/2008)
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Merck Warning Letter-
Questions and Answers (Posted: 4/30/2008)
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FDA approves Amitiza (lubiprostone) for the treatment of
irritable bowel syndrome with constipation in adult women aged 18 and
over
(4/30/2008)
April 29, 2008
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FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not
Conducted Under an Investigational New Drug Application; Final Rule
(4/29/2008)
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Actavis Totowa LLC recalls all strengths of Digitek (digoxin
tablets, USP), a drug used to treat heart failure and abnormal heart
rhythms (4/29/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 4/29/2008)
April 28, 2008
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Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
- Update (Posted: 4/28/2008, Updated as of: 4/28/2008)
-
FDA updates information to healthcare facilities and
healthcare professionals about heparin and heparin-containing medical
products (4/25/2008)
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Postmarketing Study Commitments: Introduction
(updated 4/25/2008)
-
FDA approves Relistor (methylnaltrexone
bromide) for opioid-induced constipation
(4/25/2008)
April 24, 2008
- Office of Nonprescription Products:
Rx to OTC
Switch (updated 4/24/2008)
April 23, 2008
-
Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)
- Agenda (Posted: 4/23/2008)
April 22, 2008
-
FDA approves Cimzia (certolizumab pegol) to treat Crohn's
disease (4/22/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 4/22/2008)
April 21, 2008
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Guidance for Sponsors, Industry, Researchers, Investigators, and Food
and Drug Administration Staff: Certifications To Accompany Drug,
Biological Product, and Device Applications/Submissions: Compliance with
Section 402(j) of The Public Health Service Act, Added By Title VIII of
The Food and Drug Administration Amendments Act of 2007 (Posted
4/21/2008)
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Important Product Correction Notification: Blood Grouping
Reagent Anti-S for Indirect Antiglobulin Tests
- Ortho Clinical Diagnostics, Inc (Posted: 4/21/2008, Notification Date:
4/21/2008)
- Office of Generic Drugs:
March
First-Time Generic Drug Approvals (4/18/1008)
April 17, 2008
-
Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings
with a Point-of-Care Meter Due to a Maltose-Containing Intravenous
Immune Globulin Product (Posted 4/17/2008)
-
Postmarketing Study Commitments: Introduction
(updated 4/17/2008)
April 16, 2008
-
Guidance for
Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable
Diseases Using Pooled Specimens or Diagnostic Tests (PDF - 87 KB)
(Posted 4/16/2008)
-
CDER issues "Review of Therapeutic
Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" ( 4/16/2008)
-
Drugs@FDA Downloadable Data Files
(updated 4/16/2008)
April 15, 2008
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Human Cell, Tissues and Cellular and Tissue-Based
Products (HCT/P) - Alphabetical List of Registered Establishments
- Update (Posted: 4/15/2008)
-
Paragraph IV Patent Certifications
(updated 4/15/2008)
April 14, 2008
-
Investigational Human Drugs: Clinical Investigator
Inspection List (CLIIL) (updated 4/14/2008)
-
The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
(updated 4/11/08)
- Creating New Knowledge:
FDA & Industry in Dialogue, May 6, 2008,
Philadelphia, PA. The seventh conference between the FDA and
industry sponsored by Temple University School of Pharmacy.
Keynote Speaker: Janet Woodcock, M.D., Director, CDER. This
conference provides participants, industry, and the FDA a forum for
dialogue about critical issues affecting drug development.
Agenda and registration
(4/11/08)
April 10, 2008
-
Bioresearch Monitoring Information System (BMIS)
(updated
4/10/2008)
-
Cyber Letters (updated
4/10/2008)
-
FDA issues a Communication About an Ongoing Safety Review
of CellCept and Myfortic (4/10/2008)
-
New
Drug Application (NDA) & Biologic License Application (BLA) Efficacy
Supplements Approved (CY 2008) (updated
4/10/2008)
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes (updated
4/10/2008)
-
Pfizer informs healthcare professionals and patients of
updated safety information in the labeling for Exubera, a short-acting
insulin (4/10/2008)
-
Schwarz Pharma recalls Neupro, a transdermal delivery
system used to treat early stage Parkinson’s disease, at the end of
April (4/10/2008)
-
Recall of Thymoglobulin -
Genzyme Corporation (Posted: 4/10/2008, Recall Date: 4/9/2008)
April 9, 2008
-
Fast
Track Designation Request Performance Report -
Update (Posted: 4/9/2008)
-
Guidance for FDA
Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing,
and Control (CMC) Information for Human Gene Therapy Investigational New
Drug Applications (INDs) (PDF - 251 KB) (4/9/2008)
-
Guidance for FDA
Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing,
and Control (CMC) Information for Human Somatic Cell Therapy
Investigational New Drug Applications (INDs) (PDF - 237 KB) (4/9/2008)
-
Fast
Track Designation Request Performance Report -
Update (Posted: 4/9/2008)
- Cubist Pharmaceuticals, Inc.
informs healthcare professionals that a potentially significant impurity
has been isolated from reconstituted Cubicin stored in with ReadyMED
elastomeric infusion pumps manufactured by Cardinal Health, Inc.
MedWatch Safety Information
(4/9/2008)
-
Dissolution Methods Database
(updated
4/9/2008)
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Drugs@FDA Downloadable Data Files
(updated
4/9/2008)
-
Research in the Division of Drug Marketing,
Advertising, and Communications (DDMAC) (4/9/2008)
- BPCA/Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Granted (updated 4/9/2008)
April 8, 2008
-
International
Conference on Harmonisation (ICH); Guidance for Industry: E15
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding Categories (4/8/2008)
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FDA release information on adverse events and heparin
(4/8/2008)
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Impurity Evaluation of Heparin Sodium by 1H-NMR
Spectroscopy (updated
4/8/2008)
- Guidance for Industry: Coronary
Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion
Document [PDF]
(updated 4/8/2008)
- Manuals of Policies and Procedures (MaPPs)
(updated 4/8/2008)
-
4631.3R Budget Execution Planning and
Reporting/Program Management System Reports
-
4641.5 Authority to Reimburse Employees for
Business Calls Made on Personal Car Phones
-
7700.1 Management of the Regulatory Science
and Review Enhancement Committee
-
Drug
Shortages (updated 4/8/2008)
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Current Drug Shortage: Neupro (rotigotine transdermal
system)
-
Drug to be Discontinued: Geocillin (carbenicillin
indanyl sodium) tablets 382 mg
-
FEDERAL REGISTER: Amendment to the Current Good
Manufacturing Practice Regulations for Finished Pharmaceuticals;
Withdrawal (4/4/2008)
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National Drug Code Directory Download
(updated 4/4/2008)
-
National Drug Code Directory Search
(updated 4/4/2008)
- Overview of the Regulation of Biological
Products (Blood Components and Tissues) - 3/12/2008 (Posted 4/4/2008)
-
Surveillance and Enforcement (PDF - 88 KB)
- Armando Zamora
-
The Regulation of Biological Products (PDF - 788 KB)
- Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon
O'Callaghan, Laura St. Martin, MD
-
Regulation of Biological Products - Review (PDF - 711
KB) - Judy Ciaraldi, Linda S. Mattingly,
Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
-
FDA Field Inspections (PDF - 60 KB)
- Linda S. Mattingly
-
FDA Regulation of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps) (PDF - 173 KB)
- Laura M. St. Martin, M.D., M.P.H.
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CDER Key Officials (Updated
4/4/2008)
April 2, 2008
- GlaxoSmithKline informs healthcare
professionals of changes to the prescribing information for Relenza
regarding information from postmarketing reports.
MedWatch Safety Information (4/2/2008)
-
Resolved Drug Shortage: BiCNU
(updated 4/2/2008)
-
Drugs@FDA Downloadable Data Files
(updated 4/2/2008)
- CDER Data Standards Manual:
SPL Flavor
(4/2/2008)
- Meeting: A Joint FDA/URI College of
Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June
30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD.
Meeting Information [PDF, External Site]
(4/2/2008)
-
Novartis will no longer make Zelnorm available under a
treatment IND protocol (4/2/2008)
April 1, 2008
-
FDA/NIST Sponsored Workshop: In Vitro Analyses of
Cell/Scaffold Products - Slide Presentations
(Posted: 4/1/2008)
- International Conference on
Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon,
Rockville, MD, April 4, 2008.
Meeting
Information (4/1/2008)
-
Prescription Drug User Fee Act (PDUFA) IV Drug Safety
Five-Year Plan (Draft) (PDF, 4/1/2008)
March 31, 2008
- Guidance for Industry:
Comprehensive List of Guidance Documents and
New/Revised/Withdrawn List for 2008 (Updated 3/31/2008)
-
Public Workshop: Safety of Hemoglobin-Based Oxygen
Carriers (HBOCs) - Updated Meeting Location
(Posted: 3/31/2008; Meeting Date: 4/29-30/2008)
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