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Archived Info:
Recent FDA Links
FDA Links by
Classification
-
Public Workshop: Risks and Benefits of Long-Term Use of
Nicotine Replacement Therapy (NRT) Products, October
26-27, 2010, Arlington, VA (9/2/2010)
- Guidance for Industry:
Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
(Updated: 9/2/2010):
-
Annex 11 Capillary Electrophoresis General
Chapter
-
7341.002 - Inspection of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps) (Updated: 9/1/2010)
-
Approved Risk Evaluation and Mitigation Strategies (REMS)
(Updated: 9/1/2010)
- FDA Drug Safety Communication:Increased
risk of death with Tygacil (tigecycline) compared to other antibiotics
used to treat similar infections (9/1/2010)
- Guidance for Industry:
Q4B Evaluation
and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
(Updated: 9/1/2010):
-
Annex 12 Analytical Sieving General Chapter (PDF - 88KB)
- Rulemaking History for Nonprescription
Products:
Labeling of Drug Products (Updated: 9/1/2010)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (Updated: 9/1/2010)
-
National Drug Code Database
(Updated: 9/1/2010)
-
Waivers for Conflicts of Interest for the
September 21, 2010 Vaccines and Related Biological Products Advisory
Committee Meeting (Posted: 8/31/2010)
-
September 21, 2010: Vaccines and Related
Biological Products Advisory Committee Meeting Draft Agenda (Posted: 8/31/2010)
-
September 21, 2010: Vaccines and Related
Biological Products Advisory Committee Roster (Posted: 8/31/2010)
-
September 21, 2010: Vaccines and Related
Biological Products Advisory Committee Temporary Voting Members (Posted: 8/31/2010)
-
Drug Shortages: Current Drug Shortages: Technetium Tc99m
Generators (updated 8/31/2010)
-
Medication Guides (updated
8/31/2010)
-
Postmarket Requirements and Commitments Download File (updated
8/31/2010)
- Guidance for Industry:
Individual Product Bioequivalence Recommendations (26 Newly Added
Recommendations; 10 Revised Recommendations) (Updated: 8/30/2010)
-
2010 Biological Device Application Approvals (Updated: 8/30/2010)
-
SOPP 8413: Postmarketing Commitment Related
Submissions - Administrative Handling, Review, and CBER Reporting (2) (Updated: 8/30/2010)
-
Public Workshop on Cell and Gene Therapy
Clinical Trials in Pediatric Populations (Posted: 8/27/2010)
- Development and Distribution of
Patient Medication Information for Prescription Drugs; Public Hearing,
September 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland.
Meeting information (8/27/2010)
- Generic Drug User Fee; Public
Meeting; Request for Comments, September 17, 2010, Hilton Washington
DC/Rockville and Executive Meeting Center, 1750 Rockville Pike,
Rockville, Maryland 20852.
Meeting information (8/27/2010)
-
Guidance for Industry:
Acute Bacterial Skin and Skin Structure Infections: Developing Drugs
for Treatment (PDF - 516kb)
(Updated: 8/26/2010)
-
URGENT - Voluntary Market Withdrawal of
Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation (Posted: 8/25/2010)
-
Influenza Virus Vaccine for the 2010-2011
Season (Updated: 8/25/2010)
-
Drugs@FDA Download File (Updated: 8/25/2010)
-
Drug Shortages: Current Drug Shortages:
Succinylcholine injection (Updated: 8/25/2010)
-
Drug Shortages: Current Drug Shortages: Technetium Tc99m
Generators (Updated: 8/25/2010)
-
Guidance for Industry: Electronic Submission
of Lot Distribution Reports for Biological Products (PDF
- 57KB)
August 2010 (Posted: 8/24/2010)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 8/24/2010)
-
Paragraph IV Patent Certifications
(updated 8/24/2010)
-
CDER Small Business Page
(updated 8/23/2010)
- FDA Drug Safety Podcast for
Healthcare Professionals:
Ongoing Safety Review of Stalevo and possible increased
cardiovascular risk (8/23/2010)
- FDA Drug Safety Communication:
Ongoing Safety Review of Stalevo and possible increased
cardiovascular risk (8/20/2010)
-
Drug Shortages: Current Drug Shortages:
Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) (8/20/2010)
-
Podcast for Healthcare Professionals:
Aseptic meningitis associated with use of Lamictal
(8/19/2010)
- Podcast for Healthcare
Professionals:
Serious medication errors from intravenous administration
of nimodipine oral capsules (8/19/2010)
- BPCA/Pediatric Exclusivity Statistics:
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (Updated: 8/19/2010)
-
Influenza Virus Vaccine for the 2010-2011
Season (Updated: 8/19/2010)
-
PDUFA Drug User Fee Act (PDUFA): FY
2011 Product and Establishment Fee Invoices were mailed Tuesday,
8/17/2010. Full payment of the invoice is due October 1, 2010.
If you do not receive your invoice by 8/27/2010, please contact
Ashley Jones or Beverly Friedman at 301-796-3602
(updated
8/18/2010)
- Guidance for Industry:
Organ-Specific Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human
Use — Small Entity Compliance Guide (PDF - 177KB)
(updated
8/17/2010)
- FDA Drug Safety Podcast:
Aseptic meningitis associated with use of Lamictal
(8/16/2010)
-
FDA Proposes Withdrawal of Low Blood Pressure Drug
(8/16/2010)
-
Medication Guides (updated
8/16/2010)
-
Drug Shortages: Current Drug Shortages: Naloxone
Injection
(updated 8/16/2010)
-
Drug Shortages: Current Drug Shortages: Technetium Tc99m
Generators
(updated 8/16/2010)
- FDA Drug Safety Communication:
Aseptic meningitis associated with use of Lamictal (lamotrigine)
(8/12/2010)
- FDA Drug Safety Podcast:
Avoid Unintentional Exposure of Children and Pets to
Evamist (8/12/2010)
-
SOPP 8116: Using Electronic Signatures for
Investigational and Marketing Regulatory Document Concurrence/Signoff (Updated: 8/12/2010)
-
Recent FDA Links
-
FDA Links by
Classification
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-- pharmaceutical, biotech, etc.
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-- search thousands of pharm/biotech jobs.
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Consultants
-- product development, clinical, QC, QA, etc.
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-- pharmaceutical, biotech, clinical, etc.
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Advertising On PharmCast.com
-- information, Media Planner, etc.
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Pharm/Biotech Events
-- pharmaceutical, biotech, clinical, regulatory, business development,
operation, etc.
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Software/Report/ Database
-- operation software, business intelligence, etc.
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Archived Info:
Recently Issued US Federal Register
-
Notice:
Guidance for Industry; Small Entities
Compliance Guide -- Designation of New Animal Drugs for Minor Uses or
Minor Species; Availability
-
Notice: Guidance for Industry;
Small Entities Compliance Guide -- The Index of Legally Marketed
Unapproved New Animal Drugs for Minor Species; Availability
-
Notice:
International Conference on Harmonisation;
Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the International Conference on Harmonisation Regions; Annex
12 on Analytical Sieving General Chapter; Availability
-
Notice: Risks and Benefits of
Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop;
Request for Comments
-
Notice: Prospective Grant of
Exclusive License: Use of Pentosan Polysulfate To Treat Certain
Conditions of the Prostate
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request;
Experimental Study of Format Variations in the Brief Summary of
Direct-to-Consumer Print Advertisements
-
Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; ONGLYZA
-
Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; PRISTIQ
-
Notice: Supplemental Funding
Under the Food and Drug Administration's Food Emergency Response
Laboratory Network Microbiological Cooperative Agreement Program (U18)
PAR-09-215; Request for Supplemental Applications
-
Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive,
Color Additive (Including Labeling), and Generally Recognized as Safe
Affirmation; Submission of Information to a Master File in Support of
Petitions; Electronic Submission Using Food and Drug Administration Form
3503
-
Notice: Draft Guidance for
Industry on Acute Bacterial Skin and Skin Structure Infections:
Developing Drugs for Treatment; Availability
-
Final Rule: New Animal Drugs; Change of
Sponsor; Withdrawal of Approval of New Animal Drug Applications;
Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate
Suspension
-
Notice:
Development and Distribution of Patient
Medication Information for Prescription Drugs; Public Hearing
-
Notice: Request for Comments
on Synthetic Biology
-
Notice (A): Government-Owned
Inventions; Availability for Licensing
-
Notice (B): Government-Owned
Inventions; Availability for Licensing
-
Notice:
Availability of Draft Toxicological Profile
-
Notice: Draft National
Conversation on Public Health and Chemical Exposures Work Group Reports;
Opportunity for Public Comment
-
Proposed Rule: Effective Date
of Requirement for Premarket Approval for Four Class III Preamendments
Devices
-
Notice: Guidance for Industry:
Questions and Answers Regarding the Effect of Section 4205 of the
Patient Protection and Affordable Care Act of 2010 on State and Local
Menu and Vending Machine Labeling Laws; Availability
-
Notice:
Request for Comment: National Center for
Complementary and Alternative Medicine Draft Strategic Plan
-
Notice: National Cancer
Institute's Best Practices for Biospecimen Resources
-
Notice: National Toxicology
Program (NTP); Center for the Evaluation of Risks to Human Reproduction
(CERHR); Evaluation of the Health Effects of Low-Level Lead Exposure:
Call for Information and Nomination of Scientific Experts
-
Notice: Food and Drug
Administration Clinical Trial Requirements, Regulations, Compliance, and
Good Clinical Practice; Public Workshop
-
Notice: Public Workshop on
Medical Devices and Nanotechnology: Manufacturing, Characterization, and
Biocompatibility Considerations
-
Notice: Quality and Compliance
in Merging and Emerging Cultures; Public Conference
-
Notice (A): Government-Owned
Inventions; Availability for Licensing
-
Notice (B): Government-Owned
Inventions; Availability for Licensing
-
Notice: ASK (Assess Specific
Kinds of CHILDREN Challenges for Neurologic Devices) Study Children
Workshop; Public Workshop; Request for Comments
-
Notice: Expanded Human Immunodeficiency Virus (HIV) Testing for Disproportionately Affected Populations
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Testing
Communications on the Food and Drug Administration/Center for Veterinary
Medicine's Regulated Products Used in Animals
-
Notice:
Oversight of Laboratory Developed Tests;
Public Meeting; Reopening of the Comment Period
-
Notice: Determination That
DIASTAT (Diazepam Rectal Gel), 5 Milligrams/Milliliter, 10 Milligrams/2
Milliliter, 15 Milligrams/3 Milliliter, and 20 Milligrams/4 Milliliter,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
-
Notice:
Guidance for Industry on Organ-Specific
Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human Use--Small Entity Compliance Guide;
Availability
-
Notice:
Draft Revised Guidance for Industry on
Residual Solvents in New Veterinary Medicinal Products, Active
Substances and Excipients (Revision) VICH GL18(R); Request for Comments;
Availability
-
Recently Issued Documents in the US
Federal Register
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Archived Info:
Recently Issued FDA Warning/Notice of Violation Letters
Warning/Notice
of Violation Letters
Indexed by Company Names
Recently Issued FDA Warning Letters
Warning Letters
Indexed by Company Names
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Jobs
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sales, marketing, etc.
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