- Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule June 27, 2022
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- ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules June 22, 2022
- In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs” June 21, 2022
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BioCentury This Week Explores Orphan Drugs With HP&M Attorney & NORD Board Chair
January 21, 2011On January 23rd, BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs – Why Successful Cures Bring Challenges for Patients and Payment,” will be posted on the internet here, and featues Peter Saltonstall, President & CEO of the National Organization for Rare Disorders, Frank Sasinowski, Chairman of the Board at NORD (and Hyman, Phelps & McNamara, P.C. Director), and Lauren Barnes of Avalere Health, former director of U.S. payment and coverage at Amgen. Eight of the 22 new chemical entities FDA approved in 2010 were for rare (orphan) diseases; however, the successes in the orphan drug arena are bringing new challenges, including assuring patient access as Orphan Drug prices are prompting insurance companies to consider impose prior authorization requirements, higher co-pays, and scrutinize off-label use. BioCentury This Week will explore these important issues.
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- Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule June 27, 2022
- 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away June 24, 2022
- Corporate Liability from Employee Diversion: Costly on Many Fronts June 22, 2022
- ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules June 22, 2022
- In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs” June 21, 2022
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized