- Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin December 5, 2019
- HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger December 4, 2019
- FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020 December 3, 2019
- FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process December 2, 2019
- CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements November 27, 2019
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Lawyer, Physician, and Bioethicist Takes Over the Reins at FDA’s Orphan Drug Shop
October 6, 2011By Kurt R. Karst –
We have learned that FDA’s Office of Orphan Products Development (“OOPD”) has a new Acting Director. Debra Lewis, O.D., M.B.A., who is OOPD Deputy Director, and who has been serving as Acting Director since the Departure of Dr. Timothy Coté earlier this year, announced earlier this week that Gayatri Rao, M.D., J.D. will become OOPD Acting Director starting the week of October 10th. Dr. Rao graduated from the University of Medicine and Dentistry of New Jersey Medical School and earned both her law degree and bioethics masters degree from the University of Pennsylvania. She comes to OOPD from FDA’s Office of Chief Counsel, thereby “bringing a unique medical and legal/regulatory background to move the OOPD rare disease mission forward,” Dr. Lewis wrote in an e-mail announcement.
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- Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin December 5, 2019
- HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger December 4, 2019
- FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020 December 3, 2019
- FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process December 2, 2019
- CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements November 27, 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
- 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
- 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