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Generic Drugs The United States Food and Drug Administration

167
Pharmaceutical Industry
94
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90
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83
Patents
77
ANDA
70
Hatch-Waxman
68
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57
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34
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31
SCOTUS
25
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23
Labeling
21
BPCIA
21
FDCA
17
Sandoz
16
Medical Devices
15
Amgen
15
Apotex
15
Failure To Warn
15
FTC
15
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14
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14
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12
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FDA Approval
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12
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12
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12
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11
Biologics
11
PLIVA v Mensing
10
Antitrust Litigation
10
Mylan Pharmaceuticals
10
Sandoz v Amgen
10
Teva Pharmaceuticals
9
Affordable Care Act
9
FTC v Actavis
9
Patent Dance
8
Orange Book
8
Orphan Drugs
8
Preliminary Injunctions
7
Notice Requirements
7
Patent Applications
7
Personal Jurisdiction
7
Prior Art
7
Product Exclusivity
6
Actavis Inc.
6
Class Action
6
Declaratory Judgments
6
Draft Guidance
6
Medicare
6
Mutual Pharmaceuticals v Bartlett
6
Otsuka Pharmaceutical
6
Safe Harbors
6
Summary Judgment
6
USPTO
5
Biologics Price Competition and Innovation Act of 2009
5
Corporate Counsel
5
Design Defects
5
Drug Pricing
5
GlaxoSmithKline
5
Life Sciences
5
Medicaid
5
Product Hopping
5
Product Labels
5
Proposed Regulation
5
Sherman Act
5
Watson Pharmaceuticals
4
aBLA
4
Allergan Inc
4
Amarin
4
Antitrust Violations
4
Classen Immunotherapies
4
CMS
4
Exclusivity
4
HHS
4
No-AG Agreement
4
OIG
4
On-Sale Bar
4
Pay-For-Delay
4
Proposed Legislation
3
AbbVie
3
Antitrust Provisions
3
AstraZeneca
3
Brand
3
Citizen Petitions
3
Comment Period
3
Competition
3
DOJ
3
Drug Safety
3
Elan Pharmaceuticals
3
Eli Lilly
3
Federal Rule 12(b)(6)
3
GDUFA
3
Health Care Providers
3
Healthcare Reform
3
Hospira
3
Hospitals
3
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3
Jurisdiction
3
Licensing Rules
3
Medicare Part B
3
Merck
3
Monopolization
3
Off-Label Promotion
3
Patent Invalidity
3
Pharmacies
3
Pleading Standards
3
Professional Conferences
3
Public Health Service Act
3
REMS
3
Rule-of-Reason Analysis
3
Rulemaking Process
3
Spectrum
3
Standing
3
Takeda Pharmaceuticals
3
Telehealth
3
Trademarks
2
21st Century Cures Initiative
2
Allergan v Sandoz
2
America Invents Act
2
Anti-Competitive
2
Antitrust Injuries
2
Biotechnology
2
Canada
2
Cancer
2
CDC
2
Cephalon
2
Chevron Deference
2
China
2
Class Certification
2
Clinical Trials
2
Co-Op
2
Congressional Committees
2
Congressional Investigations & Hearings
2
Contraceptive Coverage Mandate
2
DaimlerAG
2
DaimlerChrysler v Bauman
2
Dismissals
2
Drug Compounding
2
Durable Medical Equipment
2
Duty to Deal
2
E-Cigarettes
2
Endo Pharmaceuticals
2
Enforcement Actions
2
EU
2
False Advertising
2
False Claims Act (FCA)
2
First Amendment
2
Food Safety
2
Foreign Manufacturers
2
Free Speech
2
General Jurisdiction
2
Health Information Technologies
2
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2
Innovator Liability
2
Intellectual Property Litigation
2
INTERPOL
2
Learned Intermediary
2
Legislative Agendas
2
Medicare Part D
2
MedPAC
2
Medtronic
2
Mensing
2
Mental Health
2
Motion To Stay
2
Multidistrict Litigation
2
New Guidance
2
NIH
2
Off-Label Use
2
PHRMA
2
Product Defects
2
Putative Class Actions
2
Rebates
2
Roxane Laboratories
2
SNDAs
2
Substance Abuse
2
Suppliers
2
Telemedicine
2
Transfer of Venue
2
TRO
2
Twombly/Iqbal Pleading Standard
2
Unfair Competition
2
Websites
2
Wyeth
1
35 U.S.C. § 271(e)(1)
1
3D Printing
1
510(k) RTA
1
Abbott Laboratories
1
ACOs
1
Actos
1
Advance Notice
1
Alternative Payment Models (APM)
1
Amended Complaints
1
Amended Regulation
1
Anti-Monopoly
1
Antibiotics
1
Antitrust Conspiracies
1
App Developers
1
Attorney Generals
1
Australia
1
Automatic Enrollment
1
Barack Obama
1
Bayer
1
Best Practices
1
Bifurcation
1
Biogen Idec
1
Biopharmaceutical
1
Bipolar Disorder
1
Boehringer
1
Books
1
BPCI
1
Burden of Proof
1
CA Supreme Court
1
Cadillac Tax
1
CAFC
1
Cartwright Act
1
Carve Out Provisions
1
Causation
1
Center for Drug Evaluation and Research (CDER)
1
Cipro
1
Civil Monetary Penalty
1
Claim Construction
1
Clearance
1
Community Trademark
1
Compliance
1
Conflicting Proposals
1
Copyright
1
Copyright Infringement
1
Corrective Actions
1
Cost-Sharing
1
Counterclaims
1
Counterfeit Drugs
1
Counterfeiting
1
Covenant Not to Sue
1
Covered Business Method Patents
1
Daiichi Sankyo
1
Defect
1
Delaware General Corporation Law
1
Department of Veterans Affairs
1
Device Classification
1
DHS
1
Diagnostic Tests
1
Dietary Supplements
1
Direct Purchasers
1
Disclosure
1
Disclosure Requirements
1
Discovery Rule
1
Disgorgement
1
Doctrine of Equivalents
1
DOHA
1
DOL
1
DQSA
1
DSCSA
1
EAR
1
EHR
1
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1
Email
1
Employer Mandates
1
Enforcement
1
Evidence Suppression
1
Exceptional Case
1
Excessive Pricing
1
Expert Testimony
1
Exports
1
False Evidence
1
FDA Warning Letters
1
FDASIA
1
Federal Budget
1
Federal Question Jurisdiction
1
Federal Rule 12(b)(1)
1
Federal Rules of Civil Procedure
1
Fee-for-Service
1
Filing Fees
1
Final Rules
1
First Sale Doctrine
1
Food Labeling
1
Food Recalls
1
Foreign Corporations
1
Foreseeability
1
Forum Shopping
1
Fraudulent Concealment
1
FTEs
1
Generic
1
Genzyme
1
Gilead Sciences
1
Goodyear
1
Government Investigations
1
Grable Factors
1
Health Insurance
1
Health Safety
1
Highmark v. Allcare
1
Hoffman LaRoche
1
Home Health Care
1
ICD-10
1
Implied Preemption
1
Imports
1
Information Reports
1
Informed Consent
1
Injunctive Relief
1
Innovation
1
Inspections
1
Intellectual Property Protection
1
International Harmonization
1
International Treaties
1
Inventions
1
Investors
1
IRF Claim Processing
1
Janssen Pharmaceuticals
1
Johnson & Johnson
1
Justiciable Controversy
1
Kickbacks
1
Lanham Act
1
Leave to Amend
1
License Agreements
1
Licenses
1
Long Term Care Facilities
1
Manufacturing Defects
1
Market Manipulation
1
Marketing
1
Medical Foods
1
Medicare Modernization Act
1
Medicare Prescription Drug Improvement and Modernization Act (MMA)
1
Misrepresentation
1
Mootness
1
Motion for Reconsideration
1
Motion To Centralize
1
Motion to Dismiss
1
Native American Issues
1
Negligence
1
New Legislation
1
New Regulations
1
New Trial
1
Nexus
1
Nike
1
NJ Supreme Court
1
Non-Grandfathered Health Plans
1
Notice of Intent
1
Notifications
1
Novartis
1
Numerosity
1
Nursing Homes
1
Nutritional Supplements
1
Obviousness
1
Octane Fitness v. ICON
1
Open Enrollment
1
Opioid
1
OPPS
1
Out-of-State Companies
1
Out-of-State Judgments
1
OxyContin
1
PACE
1
Patent Term Extensions
1
Patent Trial and Appeal Board
1
Patent-Misuse
1
Permanent Injunctions
1
PHSA
1
Physician Fee Schedule
1
Physician Medicare Reimbursements
1
Post-Grant Review
1
Premarket Approval Applications
1
Prescription Drug Coverage
1
Presidential Elections
1
Price Transparency
1
Private Right of Action
1
Prometheus
1
Proposed Amendments
1
Public Meetings
1
Public Performance Rights
1
Public Use
1
Qui Tam
1
RanBaxy
1
Recordkeeping Requirements
1
Registration Requirement
1
Regulatory Standards
1
Renewal Fees
1
Res Ipsa Loquitur
1
Research and Development
1
Restraining Orders
1
Reversal
1
Reverse Payments
1
RICO
1
Risk Management
1
Rule 23
1
Rural Areas
1
Rural Health Care Program
1
SAMHSA
1
Sanofi
1
SEC
1
Section 340B
1
Senate Judiciary Committee
1
Settlement
1
Sham Citizen Petitions
1
Sham Litigation Exception
1
Skilled Nursing Facility
1
SmithKline Beecham
1
Social Security
1
Specific Jurisdiction
1
Spoliation
1
Standard of Review
1
State Health Insurance Exchanges
1
State Law Tort Claims
1
Subject Matter Jurisdiction
1
Supply Chain
1
Tax Credits
1
Tobacco Regulations
1
Trade Secrets
1
Trademark Registration
1
Trademark Searches
1
Transvaginal Mesh
1
Two-Midnight Rule
1
U.S. Treasury
1
Uniform Commercial Code (UCC)
1
Universal Health Services Inc v United States ex rel Escobar
1
Vaccinations
1
Veterans
1
Veterinary Products
1
Warner Chilcott
1
Webinars
1
Whistleblowers
1
WIPO
1
Women's Preventable Healthcare Mandates
1
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1
WTO
1
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