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New! George Washington University's Healthcare MBA
New! Free Pharm/Biotech Magazine Subscription
New! Pharm/Biotech Web Seminars
New! Pharmaceutical/Biotech Outsourcing Companies
New! Pharm/Biotech Training Courses
New! Executive MBA in Pharmaceutical Management
New! Pharmaceutical
Operation Software
New! Pharmaceutical Business Intelligence Studies
New! Patents/Technologies Available for
Licensing
New! Pharm/Biotech Jobs
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| CfPIE's Pharmaceutical and
Biotech Training Courses: |
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•
Pharmaceutical Production Batch Record Review May 15 &
16, 2008, Malvern, PA
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•
Effective Risk-Based Applications of Drug cGMPs and Validation
Requirements for Cosmetics and OTC Drug Products June 5
& 6, 2008, Malvern, PA |
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•
How to Implement Risk Management Principles and Activities Within
a Quality Management System June 11 & 12, 2008, Costa
Mesa, CA |
•
Cleanroom Microbiology for the Non-Microbiologist June
12 & 13, 2008, Malvern, PA
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Archived Info:
Recent FDA Links
FDA Links by
Classification
- 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)
-
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
-
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
-
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)
-
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)
-
Common Technical Document (CTD) Modules/Sections
Corresponding to Summary Data Tables in Bioequivalence Submissions to
ANDAs (updated
4/30/2008)
-
Drugs@FDA Downloadable Data Files
(updated 4/30/2008)
-
Postmarketing Study Commitments (updated
4/30/2008)
-
Merck Warning Letter-
Questions and Answers (Posted: 4/30/2008)
-
FDA approves Amitiza (lubiprostone) for the treatment of
irritable bowel syndrome with constipation in adult women aged 18 and
over
(4/30/2008)
-
FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not
Conducted Under an Investigational New Drug Application; Final Rule
(4/29/2008)
-
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)
-
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)
-
Postmarketing Study Commitments: Introduction
(updated 4/25/2008)
-
FDA approves Relistor (methylnaltrexone
bromide) for opioid-induced constipation (4/25/2008)
- Office of Nonprescription Products:
Rx to OTC
Switch (updated 4/24/2008)
-
Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)
- Agenda (Posted: 4/23/2008)
-
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)
-
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)
-
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)
-
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)
-
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)
-
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)
-
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)
-
Recent FDA Links
-
FDA Links by
Classification
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Archived Info:
Recently Issued US Federal Register
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Exports: Notification and Recordkeeping
Requirements
-
Notice: Guidance for Industry
and Food and Drug Administration Staff; Administrative Procedures for
CLIA Categorization; Availability
-
Notice: Agency Emergency
Processing Under Office of Management and Budget Review; Implementation
of Sections 222, 223, and 224 of the Food and Drug Administration
Amendments Act of 2007
-
Notice: Agency Information
Collection Activities: Proposed Collection; Comment Request; Guidance
for Industry: Fast Track Drug Development Programs: Designation,
Development, and Application Review
-
Notice: Prospective Grant of
Exclusive License: Antibody Therapeutics for the Treatment of Cancer in
Humans
-
Notice: Government-Owned
Inventions; Availability for Licensing
-
Notice: Draft Prescription
Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for
Comment
-
Notice: Availability of an
Environmental Assessment for Field Testing Mannheimia
Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live Culture
-
Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; TEKTURNA
-
Notice:
Manufacturer of Controlled Substances; Notice
of Application
-
Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; ARTEFILL
-
Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; AZILECT
-
Notice: Government-Owned
Inventions; Availability for Licensing
-
Notice: Towards an Artificial
Pancreas: A Food and Drug Administration, National Institutes of Health,
Juvenile Diabetes Research Foundation Public Workshop
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan
Drugs; Common European Medicines Agency/Food and Drug Administration
Application Form for Orphan Medicinal Product Designation (Form FDA
3671)
-
Notice:
Agency Information Collection Activities;
Submission for Office of Management and Budget Review; Comment Request;
Additional Listing Information for Medical Device Registration and
Listing
-
Notice:
National Toxicology Program (NTP); Report on
Carcinogens (RoC); Request for Public Comments
on the RoC Expert Panel's Recommendations on Listing Status for
Aristolochic Acids and Riddelliine in the 12th RoC and the Scientific
Justifications for the Recommendations
-
Notice: Prospective Grant of an Exclusive License: Therapeutics for the
Treatment of Spinal Cord Injury, Traumatic Brain Injury, and Leukemia
-
Notice: Prospective Grant of
Exclusive License: Development of Cancer Therapeutics in Humans
-
Notice: Prospective Grant of
Exclusive License: Method To Treat Psoriasis in Humans
-
Notice: Government-Owned
Inventions; Availability for Licensing
-
Final Rule: Human
Subject Protection; Foreign Clinical Studies Not Conducted Under an
Investigational New Drug Application (*Large Document, Linked Directly
to Federal Register Website)
-
Notice: Draft Guidance for
Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole
Blood and Blood Components Intended for Transfusion and Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);
Availability
-
Notice: Determination That
TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Current
Good Manufacturing Practice Regulations for Finished Pharmaceuticals
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Regulations
for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
-
Notice:
Cooperative Agreement to Support the World
Health Organization International Programme on Chemical Safety
-
Proposed Rule: Classification
of Three Steroids as Schedule III Anabolic Steroids Under the Controlled
Substances Act
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Draft Guidance for Industry: Substantiation for
Dietary Supplement Claims Made Under the Federal Food, Drug, and
Cosmetic Act
-
Notice: Draft Guidance for
Industry on Developing Coronary Drug Eluting Stents; Public Workshop
-
Notice:
Report on the Performance of Drug and
Biologics Firms in Conducting Postmarketing Commitment Studies;
Availability
-
Notice: Medtronic, Inc.
Cardiovascular Division, Santa Rosa, CA; Notice of Revised Determination
on Remand
-
Notice:
Developing Guidance on Conducting
Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large
Electronic Healthcare Data Sets; Public Workshop; Request for Comments
-
Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Medical Devices; Device Tracking
-
Notice: Government-Owned
Inventions; Availability for Licensing
-
Notice: Applications for
Duty-Free Entry of Scientific Instruments
-
Notice:
Draft 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
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Application for Food and Drug Administration
Approval to Market a New Drug
-
Recently Issued Documents in the US
Federal Register
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Covidien Pharmaceuticals Outsourcing
is a contract manufacturer specializing in high-quality solid dose
and oral liquid finished products, More....
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Continuing Education
-- MBA, etc.
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Outsourcing Guide
-- pharmaceutical, biotech, etc.
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PharmCast.com Weekly e-Newsletter
-- free subscription for busy pharm/biotech professionals.
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Hire Top Rated Pharm/Biotech Talent
-- post jobs online.
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Consultants
-- product development, clinical, QC, QA, etc.
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Archived Info:
Recently Issued FDA Warning Letters
Warning Letters
Indexed by Company Names
-
ZymoGenetics, Inc. (Recothrom™ (Thrombin, Topical (Recombinant)))
-
Zila Pharmaceuticals, Inc. (Peridex® (chlorhexidine gluconate 0.12%)
Oral Rinse)
-
Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
-
Coast Institutional Review Board (Site Inspection)
-
King Pharmaceuticals, Inc. (Avinza® (morphine sulfate extended-release
capsules) CII)
-
University of Texas Southwestern Medical Center (BMIS Inspection)
-
Replidyne, Inc. (BMIS Inspection)
-
Tomita Pharmaceutical Co., Ltd (Site Inspection)
-
Wyeth Pharmaceuticals, Inc. (Effexor XR© (venlafaxine HCI)
Tablets)
-
Kalchem International, Inc. (Pharmacy Compounding of Domperidone)
-
GlaxoSmithKline, Inc. (TYKERB (lapatinib) Tablets)
Recently Issued FDA Warning Letters
Warning Letters
Indexed by Company Names
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New! Training Courses
New! Web Seminars
-
The Drug Development Process – From Discovery to Commercialization
September 17 - 19,
2008,
Dublin, Ireland. Organized
by The Center for Professional Innovation & Education. (Other
CfPIE Training Courses)
-
Advanced Dissolution (Classroom/Online)
Organized by USP (United States Pharmacopeia). (Other
USP Training Courses)
-
Web Seminar:
The Best Approaches to Implement when Analyzing Environmental
Microbiology Out-of-Specification (OOS) Data May 29,
2008.
Speaker: Charles Gyecsek. Organized by BenAstrum, Inc.
Use promotional code PC0508 for 10% discount. (Other
BenAstrum's Web Seminars)
-
Pharmacovigilance and Risk Management Conference
June 18 - 19, 2008, London, UK. Organized by ViB Events.
-
2nd Annual Future of Pharma HR June 18-19, 2008,
Boston, MA. Organized by Jacob Fleming
Conferences.
-
Pharma 2.0
June 18-20, 2008 Philadelphia, PA.
Organized by the Institute for International Research.
-
Generic Drugs Summit June 18-20, 2008 Washington,
D.C. Organized by the Institute for International
Research.
-
Structure-Based Drug Design June 23-25, 2008,
Boston, MA. Organized by Cambridge Healthtech Institute.
-
Clinical Trials Supply and Management 2008 June 23 -
25, 2008, Philadelphia, PA.
Organized by IQPC.
-
Other Pharmaceutical and Biotech Events
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