- You Down With CGT? February 18, 2019
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Promoting Your 510(k)-Pending Device: 5 Questions About FDA’s Policy
October 20, 2016For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions About FDA's Policy," Hyman, Phelps & McNamara, P.C.'s Jeffrey K. Shapiro answers some of the most frequently asked questions.
Categories: Medical Devices
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- You Down With CGT? February 18, 2019
- FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement Industry February 15, 2019
- FDA Issues Final Guidance on Least Burdensome Provisions February 13, 2019
- FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message February 12, 2019
- And the Nominees Are…. FDA Law Blog’s Top 10 Device Posts of 2018 February 11, 2019
- 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
- Patent Baristas
- Patent Docs
- 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
- 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