- The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) May 3, 2024
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- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
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HP&M Promotes Sara Koblitz to Director
January 6, 2022Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director. Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the Orphan Drug Act, biosimilars, and the Orange Book. She assists pharmaceutical drug companies of all sizes on product lifecycle management, as well as regulatory strategies related to obtaining FDA approval, exclusivity, and patent listing. Sara also has been heavily involved in FDA-related litigation and interpretation of the Federal Food, Drug, and Cosmetic Act.
Sara joined the firm from a well-recognized intellectual property firm in 2017. Her full bio can be found here.
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- The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) May 3, 2024
- Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024
- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
- Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana April 30, 2024
- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- 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