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Generic Drugs The United States Food and Drug Administration

167
Pharmaceutical Industry
94
Pharmaceutical Patents
91
Prescription Drugs
82
Patents
78
ANDA
69
Hatch-Waxman
69
Patent Infringement
58
Patent Litigation
35
Biosimilars
30
SCOTUS
26
Preemption
23
Labeling
22
BPCIA
21
FDCA
17
Sandoz
16
Medical Devices
15
Amgen
15
Apotex
15
Failure To Warn
15
FTC
15
Patent-in-Suit
14
Appeals
14
Popular
12
Commercial Marketing
12
FDA Approval
12
Healthcare
12
Manufacturers
12
Reverse Payment Settlement Agreements
11
Antitrust Litigation
11
Biologics
11
PLIVA v Mensing
11
Warning Labels
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
Preliminary Injunctions
7
Class Action
7
Notice Requirements
7
Patent Applications
7
Personal Jurisdiction
7
Prior Art
7
Product Exclusivity
6
Actavis Inc.
6
Corporate Counsel
6
Declaratory Judgments
6
Draft Guidance
6
Medicare
6
Mutual Pharmaceuticals v Bartlett
6
Orphan Drugs
6
Product Hopping
6
Sherman Act
6
Summary Judgment
6
USPTO
5
Biologics Price Competition and Innovation Act of 2009
5
Design Defects
5
Drug Pricing
5
Life Sciences
5
Medicaid
5
Otsuka Pharmaceutical
5
Product Labels
5
Proposed Regulation
5
Safe Harbors
5
Watson Pharmaceuticals
4
aBLA
4
Amarin
4
Antitrust Violations
4
CMS
4
Exclusivity
4
GlaxoSmithKline
4
HHS
4
Jurisdiction
4
Monopolization
4
No-AG Agreement
4
OIG
4
On-Sale Bar
4
Pay-For-Delay
4
Proposed Legislation
4
REMS
3
AbbVie
3
Allergan Inc
3
Anti-Competitive
3
Antitrust Provisions
3
AstraZeneca
3
Brand
3
Citizen Petitions
3
Classen Immunotherapies
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
Inter Partes Review (IPR) Proceeding
3
Learned Intermediary
3
Licensing Rules
3
Medicare Part B
3
Merck
3
Multidistrict Litigation
3
Off-Label Promotion
3
Patent Invalidity
3
Pharmacies
3
Pleading Standards
3
Professional Conferences
3
Public Health Service Act
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
Antitrust Injuries
2
Bayer
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
Induced Infringement
2
Innovator Liability
2
Intellectual Property Litigation
2
INTERPOL
2
Legislative Agendas
2
Medicare Part D
2
MedPAC
2
Medtronic
2
Mensing
2
Mental Health
2
Motion To Stay
2
NIH
2
Off-Label Use
2
Permanent Injunctions
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
Best Practices
1
Bifurcation
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
EAR
1
EHR
1
Elder Issues
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
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 Guidance
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
PHSA
1
Physician Fee Schedule
1
Physician Medicare Reimbursements
1
Post-Grant Review
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
Work Plans
1
WTO
1
Young Lawyers