- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 2023
- Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45 September 26, 2023
- CPSC Decision Highlights Some Don’ts of Agency Rulemaking September 25, 2023
- To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA September 19, 2023
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Latest FDLI Update Magazine Features Two Articles Written by HPM Attorneys
May 20, 2008The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by three Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “FDA Moves Against Marketed Unapproved Human Drugs,” was written by Susan J. Matthees and John R. Fleder and discusses recent FDA actions against companies marketing unapproved drugs. According to the article, the FDA began an enforcement initiative with respect to such drug products in June 2006 to “ensure that all drugs marketed in the United States meet safety, effectiveness, manufacturing, and labeling standards.” Since FDA began this initiative, FDA has publicly taken action with respect to many marketed unapproved drugs, including carbinoxamine, colchincine for injection, hydrocodone, and guaifenesin. Since this article was published, FDA announced a new enforcement action against Scientific Laboratories for manufacturing and distributing several unapproved drugs.
The second article, titled “The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA,” was written by Jeffrey K. Shapiro and provides an overview of ways to obtain advance information from FDA on regulatory issues concerning medical device clearance. The article provides a helpful overview of the options available for approaching FDA as well as the pros and cons of each option.
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- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 2023
- Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45 September 26, 2023
- CPSC Decision Highlights Some Don’ts of Agency Rulemaking September 25, 2023
- To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA September 19, 2023
- 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