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Recently
Issued US Federal Register
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Notice: Draft Guidance for
Industry: Potency Tests for Cellular and Gene Therapy Products;
Availability
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Final Rule:
Distribution of Certain Drug Products by Registered Blood
Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers
That Qualify as Health Care Entities; Prescription Drug Marketing Act of
1987; Prescription
Drug Amendments of 1992; Policies, Requirements and Administrative
Procedures
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Notice: Grant of Authority for
Subzone Status; Noramco, Inc. (Pharmaceutical Intermediates), Athens, GA
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Notice: Agency Information
Collection Activities; Announcement of Office of Management and Budget
Approval; Guidance for Industry: Cooperative Manufacturing Arrangements
for Licensed Biologics
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Recall Regulations
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Clinical Trial
Sponsors: Establishment and Operation of Clinical Trial Data Monitoring
Committees
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Notice: Withdrawal of Approval
of 128 Suitability Petitions; Correction
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Notice: Draft Guidance for
Industry on New Contrast Imaging Indication Considerations for Devices
and Approved Drug and Biological Products; Availability
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Notice: Determination and
Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets
Accompanied by Emergency Use Information
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Notice: Notice of Intent To
Establish the Global AIDS Coordinator's Expert Panel on Prevention of
Mother-to-Child Transmission of HIV
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Notice: Prospective Granting
of a Co-Exclusive License
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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: Determination That
ATROVENT (Ipatropium Bromide) Inhalation Solution and 10 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; Implementation of Sections 222,
223, and 224 of the Food and Drug Administration Amendments Act of 2007
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices: Humanitarian Use
Devices
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Notice: Prospective Grant of
an Exclusive License: Therapeutics Based on Histone Deacetylase (HDAC)
Inhibitors for the Prevention and Treatment of Central Nervous System
(CNS) Metastases of Extra-CNS Origin Cancers
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Notice: Government-Owned
Inventions; Availability for Licensing
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Notice: Medical Device User
Fee and Modernization Act; Notice to Public of Web Location of 2009
Proposed Guidance Development
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Direct Final Rule: Applications for Food and
Drug Administration Approval to Market a New Drug; Postmarketing
Reports; Reporting Information About Authorized Generic Drugs
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request;
Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products
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Final Rule: Food Labeling: Health Claims;
Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
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Notice:
Technical Amendment to Listing in Schedule
III of Approved Drug Products Containing Tetrahydrocannabinols;
Withdrawal of Proposed Rule
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Notice: Draft Guidance for
Industry on End-of-Phase 2A Meetings; Availability
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Notice: Medical Devices;
Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications
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Notice: Prospective Grant of
Exclusive License: Use of Benztropinamine Analogs To Treat Psychiatric
and Neurological Disorders
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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: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific Body
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; MedWatch: Food and Drug Administration Medical
Products Reporting Program
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Notice: Topical Drug Products
Containing Papain; Enforcement Action Dates
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Notice: Ophthalmic Balanced
Salt Solutions for Ocular Surgical Procedures; Enforcement Action Dates
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Notice: Review of NIOSH Draft
Current Intelligence Bulletin, "A Strategy for Assigning the New NIOSH
Skin Notations for Chemicals"
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Notice: Guidance for Industry:
Regulation of Genetically Engineered Animals Containing Heritable rDNA
Constructs; Availability
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Notice: Draft Guidance for
Industry and Food and Drug Administration Staff; Clinical Investigations
of Devices Indicated for the Treatment of Urinary Incontinence;
Availability
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Notice: Assessment of Annual
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2009: Proposed
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Notice: Draft Problem
Formulation for Human Health Risk Assessments of Pathogens in
Land-Applied Biosolids
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Notice: Grant of Authority For
Subzone Status, Banner Pharmacaps, Inc.
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Notice: Availability of an
Environmental Assessment for Field Testing Rabies Vaccine, Live Raccoon
Poxvirus Vector
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Proposed Rule: Bovine Spongiform
Encephalopathy; Minimal-Risk Regions and Importation of Meat, Meat
Byproducts, and Meat Food Products Derived From Bovines 30 Months of Age
or Older
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Notice: Revised FSIS Testing
Methodology for Escherichia coli (E. coli) (O157:H7)
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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 (C): Government-Owned
Inventions; Availability for Licensing
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Notice:
Generic New Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year 2009
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Notice: Animal Drug User Fee
Rates and Payment Procedures for Fiscal Year 2009
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Guidance for
Industry on Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products
Marketed Without an Approved Application
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and
Nonprescription Drug Consumer Protection Act
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Notice: Ecamsule Eligibility
for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for
Human Use; Request for Safety and Effectiveness Data
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Notice:
Request for Notification From Industry Organizations
Interested in Participating in Selection Process for Nonvoting Industry
Representatives on Public Advisory Panels or Committees and Request for
Nonvoting Industry
Representatives on Public Advisory Panels or Committees
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Proposed Rule: General and
Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic
Device; Reopening of Comment Period
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Notice: Agency Information
Collection Activities; Announcement of Office of Management and Budget
Approval; State Petitions for Exemption from Preemption
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Interim Rule: Tuberculosis; Amend the Status
of New Mexico From Accredited Free to Modified Accredited Advanced
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals
Used for Diagnosis and Monitoring
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