- 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- FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input!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- FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process December 2, 2019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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HP&M’s Karla Palmer to Speak at FDLI’s Drug Quality and Security in 2016 Conference
February 9, 2016In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security Act (Title II). As industry implements new requirements, questions on office use, traceability, serialization, preemption, and licensing persist.
On February 23, 2016, the Food and Drug Law Institute (“FDLI”) will hold a one-day conference in Washington, D.C., titled “Drug Quality and Security in 2016,” to discuss the ongoing implementation of both DQSA titles and recent FDA guidance. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer will lead a breakout session on the DQSA’s Compounding Quality Act, during which she will review recently released guidance for compounders under FDC Act § 503A and § 503B and related topics (see our previous post here).
A copy of the FDLI conference agenda and information on registration is available here. FDA Law Blog readers can get a 15% discount off the registration fee by using the following discount code: 16DQSA.
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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- FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input!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- FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process December 2, 2019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