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Research Store
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Operation Software
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New! Pharm/Biotech Web Seminars
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Archived Info:
Recent FDA Links
FDA Links by
Classification
- Guidance for Industry:
FDA Regulation of PET Drug Products Questions and Answers
(PDF - 1040KB)
(updated 2/2/2012)
-
Medication Guides
(updated 2/2/2012)
-
FDA approves Gleevec (imatinib) for expanded use in
patients with rare gastrointestinal cancer (2/1/2012)
-
Pediatric List of Determinations Including Written
Request
(updated 2/1/2012)
-
Drugs@FDA Download File
(updated 2/1/2012)
-
FDA approves Kalydeco to treat rare form of
cystic fibrosis (1/31/2012)
-
The Role of CBER in the Success against
Epidemic Meningitis in Africa - MenAfriVac (PDF
- 295KB) (Posted: 1/31/2012)
-
Genomics News and Upcoming Events
(updated 1/31/2012)
- BPCA/Pediatric Exclusivity Statistics:
Pediatric Exclusivity Granted (updated 1/31/2012)
-
MedWatch Safety Alert: Treanda (bendamustine
HCL): Recall - Particulate Matter in Vial (1/30/2012)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated
1/30/2012)
- FDA Press Release:
Department of Justice files consent decree of permanent
injunction against Ranbaxy
(1/26/2012)
- eCTD:
FDA Portable Document Format (PDF) Specifications
(1/25/2012)
-
Attention Deficit Hyperactivity Disorder
(ADHD): Not Just for Kids
(1/25/2012)
- FDA Drug Safety Podcast for
Healthcare Professionals:
New risk factor for Progressive Multifocal
Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
(1/25/2012)
- Guidance for Industry:
Product Name Placement, Size, and Prominence in Advertising and
Promotional Labeling (PDF - 153KB)
(updated 1/24/2012)
- Manual of Policies and
Procedures (MAPP)
6730.1 (PDF - 64KB) Use of Review Templates in the
Office of Surveillance and Epidemiology
(updated 1/24/2012)
-
Paragraph IV Patent Certifications
(updated 1/24/2012)
-
Guidance for Industry: Preparation of IDEs
and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF
- 157KB) (Posted: 1/18/2012)
-
Drug Innovation: An ongoing update of
FDA’s Center for Drug Evaluation and Research's novel drug approvals
of calendar year 2012 (1/18/2012)
-
FDA approves Voraxaze (glucarpidase) to treat patients
with toxic methotrexate levels
(1/18/2012)
-
Inactive Ingredients Database Download
(updated 1/18/2012)
-
National Drug Code Directory
(updated
1/18/2012)
-
The Adverse Event Reporting System (AERS): Latest Quarterly Data Files
(updated 1/17/2012)
-
Notice of Risks of Purchasing Unapproved Injectable
Cancer Medications (PDF - 31KB)
(1/13/2012)
- FDA/Drug
Information Association (DIA) Cardiovascular Safety and
State-of-the-art Development Issues, April 17-18, 2012, Washington
Marriott, 1221 22nd St. NW, Washington, DC 20037
Meeting information
(1/13/2012)
- FDA Drug
Safety Communication:
New
Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
(1/13/2012)
- FDA Drug
Safety Podcast for Healthcare Professionals:
Update- Preliminary findings from ongoing investigations of
CardioGen-82
(1/13/2012)
-
-
Recent FDA Links
-
FDA Links by
Classification
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Magazine Subscription
-- free for qualified subscribers.
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Outsourcing Guide
-- pharmaceutical, biotech, etc.
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Find a Dream Job
-- search thousands of pharm/biotech jobs.
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Consultants
-- product development, clinical, QC, QA, etc.
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Buyer's Guide
-- 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: Identification of
Human Cell Lines Project
-
Notice:
Food and Drug Administration Transparency
Initiative: Exploratory Program To Increase Access to the Agency's
Compliance and Enforcement Data; Availability
-
Notice: Withdrawal of Approval
of New Animal Drug Applications
-
Notice: Annual Computational
Science Symposium; Public Conference
-
Proposed Rule:
Direct-to-Consumer Prescription Drug Advertisements; Presentation of the
Major Statement in Television and Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner; Notice of Availability of Study Data
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request;
Experimental Study of Consumer Response to Health Claims and Disclaimers
About the Relationship Between Selenium and Risk of Various Cancers
-
Notice:
Draft and Revised Draft Guidances for
Industry Describing Product-Specific Bioequivalence Recommendations;
Availability
-
Notice: Guidance for Industry
on Product Name Placement, Size, and Prominence in Advertising and
Promotional Labeling; Availability
-
Notice: Pediatric Medical
Devices; Public Workshop; Reopening of Comment Period
-
Proposed Rule: Import
Tolerances for Residues of Unapproved New Animal Drugs in Food
-
Notice: Prospective Grant of
Exclusive License: Development of T Cell Receptors and Chimeric Antigen
Receptors Into Therapeutics for Adoptive Transfer in Humans To Treat
Cancer
-
Notice (A): Government-Owned
Inventions; Availability for Licensing
-
Notice (B): Government-Owned
Inventions; Availability for Licensing
-
Notice: Guidance for Industry:
Preparation of Investigational Device Exemptions and Investigational New
Drug Applications for Products Intended To Repair or Replace Knee
Cartilage; Availability
-
Notice: Determination That
PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
-
Notice: Ethical and Regulatory
Challenges in the Development of Pediatric Medical Countermeasures;
Public Workshop
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Substances
Generally Recognized as Safe: Notification Procedure
-
Notice: United States
Pharmacopeial Convention; Filing of Food Additive Petition; Amendment
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Healthcare
Professional Survey of Prescription Drug Promotion
-
Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Antimicrobial Animal Drug
Distribution Reports Under Section 105 of the Animal Drug User Fee
Amendments of 2008
-
Notice: Availability of the
Report on the International Workshop on Alternative Methods To Reduce,
Refine, and Replace the Use of Animals in Vaccine Potency and Safety
Testing: State of the Science and Future Directions
-
Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Implementation of Sections 222, 223, and 224 of
the Food and Drug Administration Amendments Act of 2007
-
Notice: Medical Devices;
Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications
-
Notice: Determination That
AVALIDE (Hydrochlorothiazide and Irbesartan), Oral Tablets, 25
Milligrams/300 Milligrams and 12.5 Milligrams/75 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
-
Notice: Privacy Act of 1974;
Report of an Altered System of Records, Including Addition of Routine
Uses to an Existing System of Records; Bioresearch Monitoring
Information System
-
Notice: National Vaccine
Injury Compensation Program: Revised Amount of the Average Cost of a
Health Insurance Policy
-
Notice: Draft Guidance for
Industry and Food and Drug Administration Staff; Medical Device
Classification Product Codes; Availability
-
Proposed Rule: Amendments to
Regulations on Citizen Petitions, Petitions for Stay of Action, and
Submission of Documents to Dockets
-
Final Rule: Revisions to
Labeling Requirements for Blood and Blood Components, Including Source
Plasma
-
Notice: Draft Guidance for
Industry on Use of Histology in Biomarker Qualification Studies;
Availability
-
Notice: Draft Guidance for
Industry on Responding to Unsolicited Requests for Off-Label Information
About Prescription Drugs and Medical Devices; Availability
-
Notice: Guidance for Industry:
Current Good Tissue Practice and Additional Requirements for
Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based
Products; Availability
-
Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Revisions
to Labeling Requirements for Blood and Blood Components, Including
Source Plasma
-
Recently Issued Documents in the US Federal Register
Back
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First Page:
Patents/News etc.
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News
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Web Seminars --
pharmaceutical, biotech, clinical, etc.
eting, etc..
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PharmCast.com Weekly e-Newsletter
-- free subscription for busy pharm/biotech professionals.
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Pharm Bus Intell & Healthcare Studies
-- oncology and healthcare studies (5% discount), More...
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Consultants
-- product development, clinical, QC, QA, etc.
|
Advertising On PharmCast.com
-- information, Media Planner, etc.
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Woodbury College's Master of Science in Law degree
helps non-lawyers gain legal knowledge, More....
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FDA Warning
Letters/Notice of Violation Letters |
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
-- pharmaceutical, biotech, R&D, clinical, regulatory, QA/QC,
sales, marketing, etc.
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Pharm/Biotech Events
-- pharmaceutical, biotech, clinical, regulatory, business development,
operation, etc.
|
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Continuing Education
-- MBA, etc. |
| |
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New! Training Courses
New! Web Seminars
-
The Drug Development Process - From Discovery to
Commercialization March 14 – 16 ,
2012,
Berlin, Germany. Organized by The Center for Professional
Innovation & Education. (Other
CfPIE Training Courses)
-
ON-DEMAND Recorded Webinar: Elemental Impurities Overview Organized by USP (United
States Pharmacopeia). (Other
USP Training Courses)
-
MAGI's Clinical Research Conference - 2012 EAST May
20 - 23, 2012, Arlington, VA. Organized by iiBIG (International
Institute for Business Information & Growth LLC).
-
Pharma
Outsourcing & Procurement Summit 2012 May 21 - 22, 2012,
Berlin, Germany. Organized by World Trade Group.
-
The 7th Annual World Health Care Congress-Europe May
23 - 24, 2012, Amsterdam, Netherlands.. Organized by
World Congress.
-
The 3rd Annual World Congress of NeuroTalk May
25-28, 2012, Beijing, China. Organized by BIT World
Congress, Inc.
-
13th Annual Drug Discovery Leaders Summit June 11 &
12, 2012, Zurich, Switzerland. Organized by Oxford
Global Conferences.
-
4th Annual Drug Development Summit June 11 & 12,
2012, Zurich, Switzerland. Organized by Oxford Global
Conferences.
-
2nd Annual Achieving Clinical & Regulatory Excellence in
Turkey, the Middle East & North Africa June 11 - 14, 2012, Istanbul, Turkey. Organized by NextLevel Pharma.
-
The 1st Annual International Symposium of Hematology -2012
June 15-17, 2012, Beijing, China. Organized by BIT World
Congress, Inc.
-
Other Pharmaceutical and Biotech Events
Back
to Top Navigational Aid
First Page:
Patents/News etc.
(Patents
;
News
; Stock Quotes)

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