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- 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- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
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RAPS Wisconsin Chapter Webcast: Device Requirements for Drug-Led Combination Products
June 7, 2021The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Hyman, Phelps & McNamara, P.C.’s Adrienne Lenz will be the speaker. This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), registration and listing, and post market reporting. Attendees will gain a broad understanding of integrating device requirements into plans for development, NDA submission, and post market compliance. A live Q&A portion with the speaker will follow the presentation.
FDA Law Blog readers are offered a discount of $5 off the RAPS member and nonmember prices. ($5 for RAPS members and $20 for nonmembers). The discount code is: CHAPSPK5315DF. You can access the webcast information and sign up for the event on the RAPS website.
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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- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024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