- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the Table January 11, 2021
- When Will the Emergency End? January 11, 2021
- The Long and Winding Road: DEA Issues Final Marijuana Registration Rule January 8, 2021
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Phase 2 Sunshine Reporting Information Released By CMS
May 23, 2014By Alan M. Kirschenbaum –
CMS has posted relevant dates, instructions and other information regarding “Phase 2” of the 2014 reporting process under the Physician Payment Sunshine Act. (Background on this law and the 2014 reporting process can be found here.) CMS announced that Phase 2 of the Open Payments data submission, during which applicable manufacturers will report, and attest to the accuracy of, detailed data concerning each payment to physicians and teaching hospitals during the last five months of 2013, will begin on June 1 and end at close of business on June 30. (Phase 1, which ended on March 31, involved the submission of aggregate data only.)
Among the newly-posted information on CMS’ Open Payments web site are detailed instructions for the Phase 2 submission, a Phase 2 tutorial, updated submission data mapping documents (i.e., templates), and the text of the lengthy attestations that applicable manufacturers will have to make in order to submit the required payment data. These materials and other information can be found on CMS’ Open Payments website here.
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- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the Table January 11, 2021
- When Will the Emergency End? January 11, 2021
- The Long and Winding Road: DEA Issues Final Marijuana Registration Rule January 8, 2021
- 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