Dena Kessler

Dena Kessler

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New Guidance for 503B Outsourcing Facilities

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more

12/2/2014 - Drug Compounding FDA FFDCA New Guidance Pharmacies Registration

Ebola and Emergency Access to FDA Unapproved Drugs in Life-Threatening Situations

As public health officials accelerate their efforts to develop a vaccine to combat Ebola—one that the U.S. Food and Drug Administration (FDA) has not yet approved for use—some may ask if there is ever an option for critically...more

11/3/2014 - Drugs Ebola FDA Healthcare Medical Emergencies

It Is Finally Here-the Sun Shines on a New Era

The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more

10/6/2014 - Affordable Care Act CMS Health Care Providers Hospitals Manufacturers Pharmaceutical Manufacturers Physician Medicare Reimbursements Sunshine Act

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

9/22/2014 - Anti-Kickback Statute Co-payments False Claims Act Medicare Medicare Part D OIG Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

DEA Authorizes Take-Back Programs for Pharmacies

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

9/15/2014 - DEA Pharmaceutical Pharmacies Prescription Drugs

Recent Updates on Reimbursing Creditors' Legal Fees Under a Chapter 11 Plan

Unsecured creditors in chapter 11 cases face the prospect of two financial blows: the possibility of not receiving full payment of their claims and the cost of attorney's fees for defending their interests....more

6/21/2013 - Attorney's Fees Chapter 11 Creditors Legal Costs Reimbursements

Always Be Prepared: Forecasting a Business Partner's Financial Problems and How to Prepare

As the American economy continues to slog through the ongoing Great Recession, even financially sound companies face challenges due to the continued economic malaise. In particular, a company that works with suppliers,...more

4/19/2013 - Adequate Assurances Business Development Client Services Contract Claims Creditors Debtors Fraud Insolvency Licenses Unsecured Creditors

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