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Pharmaceutical Industry › Food and Drug Administration (FDA) › Audits

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Oberheiden P.C.

FDA Inspection Audit? What to Expect

Oberheiden P.C. on

The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants and...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

Snell & Wilmer

President Trump Issues Executive Order to “Buy American” with Respect to “Essential Medicines”

Snell & Wilmer on

Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

Cadwalader, Wickersham & Taft LLP on

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Mintz

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

Mintz on

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

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