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Generic Drugs The United States Food and Drug Administration

145
Pharmaceutical Industry
80
Pharmaceutical Patents
74
Prescription Drugs
70
Patents
67
ANDA
59
Hatch-Waxman
56
Patent Infringement
46
Patent Litigation
34
Biosimilars
29
SCOTUS
23
Preemption
22
Labeling
20
BPCIA
17
FDCA
16
Sandoz
15
Amgen
15
Apotex
15
Medical Devices
13
Appeals
13
FTC
12
Failure To Warn
12
FDA Approval
11
Commercial Marketing
11
Healthcare
11
Manufacturers
11
Popular
11
Reverse Payment Settlement Agreements
10
Biologics
10
PLIVA v Mensing
10
Sandoz v Amgen
10
Warning Labels
9
Antitrust Litigation
9
FTC v Actavis
9
Patent Dance
8
Affordable Care Act
8
Mylan Pharmaceuticals
8
Orphan Drugs
8
Preliminary Injunctions
7
Notice Requirements
7
Orange Book
7
Prior Art
7
Teva Pharmaceuticals
6
Draft Guidance
6
Medicare
6
Mutual Pharmaceuticals v Bartlett
6
Otsuka Pharmaceutical
6
Patent-in-Suit
6
Safe Harbors
6
Summary Judgment
6
USPTO
5
Actavis Inc.
5
Biologics Price Competition and Innovation Act of 2009
5
Declaratory Judgments
5
Design Defects
5
Medicaid
5
Personal Jurisdiction
5
Product Hopping
5
Product Labels
4
aBLA
4
Class Action
4
CMS
4
Corporate Counsel
4
Drug Pricing
4
Exclusivity
4
HHS
4
Life Sciences
4
No-AG Agreement
4
OIG
4
On-Sale Bar
4
Patent Applications
4
Pay-For-Delay
4
Proposed Legislation
4
Proposed Regulation
4
Sherman Act
4
Watson Pharmaceuticals
3
AbbVie
3
Allergan Inc
3
Amarin
3
AstraZeneca
3
Classen Immunotherapies
3
Comment Period
3
DOJ
3
Drug Safety
3
Federal Rule 12(b)(6)
3
GDUFA
3
GlaxoSmithKline
3
Health Care Providers
3
Healthcare Reform
3
Hospira
3
Hospitals
3
Inter Partes Review Proceedings
3
Jurisdiction
3
Licensing Rules
3
Medicare Part B
3
Merck
3
Off-Label Promotion
3
Patent Invalidity
3
Pharmacies
3
Product Exclusivity
3
Professional Conferences
3
Public Health Service Act
3
Rule-of-Reason Analysis
3
Rulemaking Process
3
Spectrum
3
Telehealth
3
Trademarks
2
21st Century Cures Initiative
2
America Invents Act
2
Antitrust Injuries
2
Antitrust Provisions
2
Biotechnology
2
Brand
2
Canada
2
Cancer
2
CDC
2
Chevron Deference
2
China
2
Citizen Petitions
2
Clinical Trials
2
Co-Op
2
Congressional Committees
2
Congressional Investigations & Hearings
2
Contraceptive Coverage Mandate
2
DaimlerAG
2
DaimlerChrysler v Bauman
2
Drug Compounding
2
Durable Medical Equipment
2
Duty to Deal
2
E-Cigarettes
2
Elan Pharmaceuticals
2
Eli Lilly
2
Endo Pharmaceuticals
2
EU
2
False Advertising
2
False Claims Act (FCA)
2
First Amendment
2
Food Safety
2
Foreign Manufacturers
2
Free Speech
2
Health Information Technologies
2
Induced Infringement
2
Intellectual Property Litigation
2
INTERPOL
2
Legislative Agendas
2
Medicare Part D
2
MedPAC
2
Medtronic
2
Mensing
2
Mental Health
2
Monopolization
2
Motion To Stay
2
Multidistrict Litigation
2
New Guidance
2
NIH
2
PHRMA
2
Putative Class Actions
2
Rebates
2
REMS
2
Standing
2
Substance Abuse
2
Suppliers
2
Takeda Pharmaceuticals
2
Telemedicine
2
TRO
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
Advance Notice
1
Allergan v Sandoz
1
Alternative Payment Models (APM)
1
Amended Complaints
1
Amended Regulation
1
Anti-Competitive
1
Antibiotics
1
Antitrust Conspiracies
1
App Developers
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
Center for Drug Evaluation and Research (CDER)
1
Cephalon
1
Cipro
1
Civil Monetary Penalty
1
Claim Construction
1
Class Certification
1
Clearance
1
Community Trademark
1
Competition
1
Compliance
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
Disgorgement
1
Dismissals
1
Doctrine of Equivalents
1
DOHA
1
DOL
1
DQSA
1
DSCSA
1
EAR
1
EHR
1
Elder Issues
1
Email
1
Employer Mandates
1
Enforcement
1
Enforcement Actions
1
Exceptional Case
1
Exports
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
FTEs
1
General Jurisdiction
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
Imports
1
Information Reports
1
Informed Consent
1
Injunctive Relief
1
Innovator Liability
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
Learned Intermediary
1
Leave to Amend
1
License Agreements
1
Licenses
1
Long Term Care Facilities
1
Manufacturing Defects
1
Medical Foods
1
Misrepresentation
1
Mootness
1
Motion for Reconsideration
1
Motion To Centralize
1
Motion to Dismiss
1
Native American Issues
1
New Legislation
1
New Regulations
1
New Trial
1
Nike
1
Non-Grandfathered Health Plans
1
Notice of Intent
1
Notifications
1
Novartis
1
Nursing Homes
1
Nutritional Supplements
1
Obviousness
1
Octane Fitness v. ICON
1
Open Enrollment
1
OPPS
1
Out-of-State Companies
1
OxyContin
1
PACE
1
Patent Term Extensions
1
Patent Trial and Appeal Board
1
Patent-Misuse
1
Permanent Injunctions
1
Physician Fee Schedule
1
Physician Medicare Reimbursements
1
Pleading Standards
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
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
Research and Development
1
Restraining Orders
1
Reversal
1
Reverse Payments
1
RICO
1
Risk Management
1
Roxane Laboratories
1
Rural Areas
1
Rural Health Care Program
1
SAMHSA
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
SNDAs
1
Social Security
1
Specific Jurisdiction
1
Standard of Review
1
State Health Insurance Exchanges
1
State Law Tort Claims
1
Supply Chain
1
Tax Credits
1
Tobacco Regulations
1
Trade Secrets
1
Trademark Registration
1
Trademark Searches
1
Transfer of Venue
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