K&L Gates LLP|192 - What the FDA's Botox Warning Letter Means for DSCSA Compliance
Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.
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Publicat05 aug. 2026
Durată12:00
Episoade
192-
What the FDA's Botox Warning Letter Means for DSCSA Compliance
Ascultate
05 aug. 2026
191-
No Surprises Act Check-In: The Latest Changes to the IDR Process
Ascultate
23 iun. 2026
190-
HIPAA Modernization: HHS's Proposed Privacy and Security Rule Updates
Ascultate
26 mai 2026
189-
Privileged Matters: A Closer Look at Attorney-Client Privilege
Ascultate
19 mai 2026
188-
Next Steps for Provider-Based Departments After the Consolidated Appropriations Act of 2026
Ascultate
20 apr. 2026
187-
LEAD the Way: An 8-Minute Primer on Accountable Care's Next Chapter
Ascultate
16 apr. 2026
186-
340B Drug Pricing Program: Rebate Model Considerations
Ascultate
25 mar. 2026
185-
A Closer Look at HHS's RFI on Accelerating the Adoption of AI in Clinical Care
Ascultate
05 mar. 2026
184-
RWI in Healthcare M&A: Part 2
Ascultate
29 ian. 2025
183-
RWI in Healthcare M&A: Part 1
Ascultate
11 dec. 2024
182-
Veterans Day Special Episode: Combating Traumatic Brain Injury
Ascultate
11 nov. 2024
181-
Corporate Practice of Medicine: New Relevance in a Changing World
Ascultate
09 apr. 2024
180-
Health System Cybersecurity Risks: Part Two
Ascultate
01 apr. 2024
179-
Health System Cybersecurity Risks: Part One
Ascultate
26 mar. 2024
178-
Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast
Ascultate
05 mar. 2024
177-
FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors
Ascultate
12 oct. 2023
176-
Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations
Ascultate
08 sep. 2023
175-
Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement
Ascultate
22 aug. 2023
174-
The End of Continuous Medicaid Enrollment—What Health Systems Should Know
Ascultate
12 iul. 2023
173-
Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?
Ascultate
27 iun. 2023
172-
Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials
Ascultate
01 iun. 2023
171-
2022 Health Care Employment Law Year in Review
Ascultate
29 mar. 2023
170-
Rural Emergency Hospitals — Transformative Change or Limited Impact?
Ascultate
21 mar. 2023
169-
Stark Law and the Anti-Kickback Statute Under the False Claims Act
Ascultate
12 ian. 2023
168-
Recent Developments to the 340B Drug Pricing Program
Ascultate
15 dec. 2022
167-
The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted
Ascultate
29 nov. 2022
166-
New Data Available Under the Hospital Price Transparency Rule
Ascultate
14 nov. 2022
165-
Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight
Ascultate
26 sep. 2022
164-
Cybersecurity & HIPAA: NIST's Practical Guidance Updates for Covered Entities and Business Associates
Ascultate
29 aug. 2022
163-
Genesis Healthcare and the 340B Program Patient Definition
Ascultate
09 aug. 2022
162-
Medicare Advantage False Claims Act Developments
Ascultate
02 aug. 2022
161-
Hospitals, Physician Practices, and Labs – Are You Ready to Report Private Payor Rates for Laboratory Tests?
Ascultate
05 iul. 2022
160-
The Drive to Align ESG and Health Equity Priorities With Medicare Reimbursement Models
Ascultate
07 iun. 2022
159-
Regulatory, Contractual, and Governance Considerations for Data Transactions
Ascultate
10 mai 2022
158-
Medical Laboratories Under the Microscope
Ascultate
22 apr. 2022
157-
Navigating the Independent Dispute Resolution Process Under the No Surprises Act
Ascultate
30 mar. 2022
156-
2021 Health Care Employment Law Year in Review and a Look Forward
Ascultate
23 mar. 2022
155-
Medicare Reimbursement for Community Hospital Residency Programs
Ascultate
31 ian. 2022
154-
Data Security Breaches in the Health Care Sector
Ascultate
20 ian. 2022
153-
What Health Care Providers Should Expect in an FDA Inspection
Ascultate
28 oct. 2021
152-
An Update on the CMS Hospital Price Transparency Rule
Ascultate
21 oct. 2021
151-
FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations
Ascultate
07 oct. 2021
150-
No Surprises: New Balance Billing Regulations for Health Care Providers
Ascultate
16 sep. 2021
149-
CMS's Proposal for New Remote Therapeutic Monitoring Codes under the 2022 Medicare Physician Fee Schedule
Ascultate
19 aug. 2021
148-
Key Considerations for Officers and Directors of Distressed Companies
Ascultate
17 aug. 2021
147-
Cybersecurity Risk in the Health Care Industry
Ascultate
09 aug. 2021
146-
When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives
Ascultate
15 iul. 2021
145-
OFCCP Enforcement in the Health Care Space
Ascultate
08 iul. 2021
144-
Understanding OIG and CMS Audits
Ascultate
10 iun. 2021
143-
The Power of Health Care: Renewable Energy Transactions from the Health Care Perspective