- 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
HP&M’s Jeff Shapiro to Speak at FDLI Combination Products Workshop
November 24, 2015As combination products continue to increase in number and complexity, FDA has shifted its focus to developing more effective ways to review them. While FDA has strived to clarify regulatory requirements and coordinate product reviews among the various centers, it is often difficult to know how a product will be classified and, as a result, what center will be tasked with reviewing its application.
On December 17, 2015, the Food and Drug LawInstitute (“FDLI”) will hold a workshop in Washington, D.C., titled “Combination Products Workshop – A Comprehensive Overview,” that is intended to provide a comprehensive look at how FDA makes its jurisdictional decisions, how a company can file a persuasive, accurate Request for Designation, and how to understand and fulfill the manufacturing practices required. Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will participate on a panel at the workshop focusing on streamlined cGMP requirements, including the draft guidance issued earlier this year.
A copy of the FDLI workshop agenda and information on registration is available here. FDA Law Blog readers can get a 15% discount by using speaker referral code COMBO15.
Search FDA Law Blog
Subscribe
Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail.
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- 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