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Recently
Issued US Federal Register
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Notice: Guidance for Industry
on Labeling Over-the-Counter Human Drug Products--Questions and Answers;
Availability
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Notice: Training Program for
Regulatory Project Managers; Information Available to Industry
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Notice: Draft Guidance for
Industry and Food and Drug Administration Staff; Assay Migration Studies
for In Vitro Diagnostic Devices; Availability
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Notice: "Guidance for
Industry: Substantiation for Dietary Supplement Claims Made Under
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act;"
Availability
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Notice: King Pharmaceuticals,
Inc. and Alpharma Inc.; Agreement Containing Consent Order To Aid Public
Comment
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Notice: Guidance for Industry
and Food and Drug Administration Staff; Class II Special Controls
Guidance Document: Nucleic Acid Amplification Assay for the Detection of
Enterovirus RNA; Availability
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Notice: Notice of Availability
of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1
Status of Germany and Poland
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Experimental
Evaluation of the Impact of Distraction on Consumer Understanding of
Risk and Benefit Information in
Direct-to-Consumer Prescription Drug Broadcast Advertisements
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; General
Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions
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Notice: Government-Owned
Inventions; Availability for Licensing
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Financial
Disclosure by Clinical Investigators
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Notice of Participation
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Notice:
Teva Pharmaceutical Industries Ltd. and Barr
Pharmaceuticals, Inc; Analysis of Agreement Containing Consent Orders To
Aid Public Comment
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Notice: Assessment of Annual
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2009
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Notice:
Controlled Substances: Established Initial
Aggregate Production Quotas for 2009
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Notice: Scientific Workshop To
Inform EPA's Response to National Academy of Science Comments on the
Health Effects of Dioxin in EPA's 2003 Dioxin Reassessment
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Notice: Regulatory Site Visit Training Program
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Notice: Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
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Notice: SEQC--The Sequencing
Quality Control Project
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot
Project Proprietary Name Review
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Notice:
Compliance Policy Guide; Radiofrequency
IdentificationFeasibility Studies and Pilot Programs for Drugs; Notice
to Extend Expiration Date
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Notice:
Draft Guidance for Industry and Food and Drug
Administration Staff; Class II Special Controls Guidance Document:
Tissue Expander; Availability
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Proposed Rule: General and Plastic Surgery
Devices: Proposed Classification for the Tissue Expander
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Notice: Grant of Authority for
Subzone Status, Amgen Manufacturing Limited (Biotechnology and
Healthcare Products), Juncos, Puerto Rico
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Notice:
Guidance for Industry on Diabetes
Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies
to Treat Type 2 Diabetes; Availability
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Notice: Determination That
RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were
Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Recall Authority
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Emergency Shortages Data
Collection System (formerly "Emergency Medical Device Shortages Program
Survey")
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Notice:
Clinical Studies of Safety and Effectiveness
of Orphan Products
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Notice: Draft Guidance for
Industry on Anesthetics for Companion Animals; Availability
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Export of
Food and Drug Administration Regulated Products: Export Certificates
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Blood Establishment Registration and Product
Listing, Form FDA 2830
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Notice:
Guidance for Industry on Orally
Disintegrating Tablets; Availability
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Notice: Draft Guidance for
Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and
Products: Recommended Approaches; Availability
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Notice: Draft Guidance for
Industry on Bioequivalence Recommendation for Vancomycin HCl;
Availability
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Notice: Draft Guidance for
Industry on Changes to Approved New Animal Drug Applications--New Animal
Drug Applications Versus Category II Supplemental New Animal Drug
Applications; Availability
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Notice: Draft Guidance for Industry on
Postmarketing Adverse Event Reporting for Medical Products and Dietary
Supplements During an Influenza Pandemic; Availability
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarketing Adverse Drug
Experience Reporting
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Notice:
Agency Information Collection Activities;
Submission for Office of Management and Budget Review; Comment Request;
Medical Devices: Humanitarian Use Devices
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Notice:
Advisory Committees; Filing of Closed Meeting
Reports
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request;
Experimental Study of the Impact of Coupons Embedded in
Direct-to-Consumer Prescription Drug Print Advertisements on Consumer
Perceptions of Product Risks and Benefits
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Notice:
Seeking To Evaluate Commercial Products, or
Products in Development, for In Vitro Serological Diagnosis of Pertussis
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Notice: Draft Guidance for
Industry and Food and Drug Administration Staff; Submission and Review
of Sterility Information in Premarket Notification Submissions for
Devices Labeled as Sterile; Availability
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Notice: Withdrawal of Certain Proposed Rules and Other Proposed Actions
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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
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Notice: Your Druggist
Pharmacy; Revocation of Registration
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Notice:
Draft Guidance for Industry on Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products Marketed
Without anApproved Application as Required by the Dietary Supplement and
Nonprescription Drug
Consumer
Protection Act: Revision 1; Availability
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Notice:
Draft Guidance for Industry: Questions and
Answers Regarding the Labeling of Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act:
Revision 1; Availability
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Notice: Guidance for Industry
and the Food and Drug Administration; Modifications to Devices Subject
to Premarket Approval--the Premarket Approval Supplement Decisionmaking
Process; Availability
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Notice: Quality Assurance
Requirements for Respirators; Notice of Proposed Rulemaking
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Notice: Government-Owned
Inventions; Availability for Licensing
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Final Rule: Rules of Practice
Before the Board of Patent Appeals and Interferences in Ex Parte
Appeals; Delay of Effective and Applicability Dates
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Notice: Sentinel Initiative:
Structure, Function, and Scope; Public Workshop; Request for Comments
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Notice:
Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics; Availability
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request;
Reclassification Petitions for Medical Devices
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Notice: Draft Guidance for
Industry on the Submission of Patent Information for Certain Old
Antibiotics; Availability
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Final Rule: Import and
Production Quotas for Certain List I Chemicals
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Notice:
Proposed Substances To Be Evaluated for Set
23 Toxicological Profiles
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Notice (A): Government-Owned
Inventions; Availability for Licensing
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Notice (B): Government-Owned
Inventions; Availability for Licensing
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Notice: Guidance for Sponsors,
Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw
From FDA-Regulated Clinical Trials; Availability
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Notice:
Manufacturer of Controlled Substances; Notice
of Registration
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