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Abbreviated New Drug Application (ANDA) › Audits › Food and Drug Administration (FDA)

Foley & Lardner LLP

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and...

Foley & Lardner LLP on

Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more

Tarter Krinsky & Drogin LLP

Hatch-Waxman Litigation Costs Both Capital Expenditures And Ordinary Business Expenses

Tarter Krinsky & Drogin LLP on

Under the Internal Revenue Code (“Code”) Section 162, ordinary and necessary business expenses are deductible, but Code Section 263 disallows a deduction for capital expenditures (“no deduction shall be allowed” for a capital...more

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