Regulations
By Kathlyn Stone, About.com Guide
Pharmaceutical regulations spanning the FDA approval process, intellectual property rights and health care legislation.
U.S. Food and Drug Administration
After a drug sponsor has screened a new drug for safety in animals, future development of the drug falls under the regulatory authority of the U.S. Food and Drug Administration. The FDA's regulatory authority includes oversight, inspection, review, approval and recalls.
- Pharmas and FDA Inspections
- Diabetes Drug Approval Process
- Abbreviated New Drug Application
- Over-the-Counter Drugs
- FDA Seeks Input on Modernizing Clinical Trials Regs
- FDA Requires Addition To Clinical Trial Informed Consent Documents
- Current Good Manufacturing Practices (cGMPs)
- Firms Make FDA Adverse Event Report Data Accessible
- Ways the FDA Supports Orphan Drug Development
- PhRMA Pushes FDA To Allow 'Truthful' Off-Label Marketing
Legislation
Laws and policies that impact the pharmaceutical industry including the Affordable Care Act, the Prescription Drug Fee, drug importation and Internet piracy.
- How are Pharma Companies Preparing for Changes to U.S. Health Care?
- Health Care Reform Implementation Schedule For Pharmas
- Pharmas and the Stop Internet Piracy Act
- The Patent Reform Act of 2011 and the Pharmaceutical Industry
- Are Pay-for-Delay Settlements History?
- U.S. Policy on Drug Importation
- 2012 Renewal of the Prescription Drug User Fee Act (PDUFA)
- Mechanics of Assessing the Prescription Drug Fee
Intellectual Property
How do intellectual property rules and regulations impact the pharmaceutical industry? How will changes to the U.S. health care system affect pharmaceutical companies?