SHARLIN CONSULTING SERVICES

Joshua Sharlin, PhD

Expert Witness: FDA Regulations
Former FDA Reviewer

Experience supporting attorneys in cases involving;
(i) death or injury caused by drugs, biologics or medical devices, (ii) patents,
(iii) insurance claims, (iv) wrongful termination, (v) trade secrets,
(vi) product labeling, (vii) merger and acquisitions
25+ Years of Consulting Experience with FDA-regulated Companies

Expert Witness Cases

1. Analyze FDA’s medical device safety database to show a company failed to report incidents about their medical device resulting in death.

2. For a hip implant, identify pre- and post-approval actions and inactions by the medical device manufacturer that were noncompliant with FDA’s regulatory requirements.

3. Explain how a drug company’s inadequate Medication Guide fulfillment processes failed to meet FDA’s regulatory requirement for supplying a Medication Guide with every drug prescription.

4. Explain how a drug company’s manufacturing compliance failure negated their business loss insurance claim made after physical damage to their manufacturing facility.

5. For a hip implant, describe the medical device manufacturer’s lack of FDA compliance in their efforts to obtain a 510(k) approval.

6. Conduct an FDA regulatory review of medical device company’s actions after the installation of their implantable pulse generator (intended to relieve pain) caused harm.

7. For a hip implant, describe the medical device company’s non-compliance with FDA’s labeling and reporting requirements for adverse event information.

8. Write a report explaining why the Warning Section in the label for a generic version of sulindac was deficient.

9. Write a report confirming a drug manufacturer’s processes for establishing the stability of a drug product met FDA’s compliance requirements.

10. Review a clinical study intended to compare the effectiveness of two drugs. Show the study’s design was manipulated to mask the weakness of one drug over the other.

11. Find weaknesses in a defense expert’s report on the adverse event reporting of fentanyl.

12. Evaluate FDA compliance in reporting adverse event information about Actos.

13. Deposed about the responsibilities of an Institutional Review Board in a wrongful firing case.

14. Testify for the defendant in a fertility clinic damages case. Explain the process and predictability of FDA approval of a drug under development.

15. Analyze the content of a drug IND submission to identify trade secret content.

16. Identify FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug and the describe the resulting deficiencies in the drug’s label.

17. Analyze the adverse event reporting for a drug that treats Attention Deficit Hyperactivity Disorder (ADHD) to determine if the drug’s label meets FDA regulatory requirements.

18. For a schizophrenia drug, analyze the growing body of scientific literature about the drug and determine if the company’s updates to the drug label’s safety information were FDA compliant.

19. Support a medical device company’s claim for monetary damages by showing how infringement of their patent solved a regulatory compliance problem of the Defendant.

20. Explain how achieving drug development milestones triggered a disputed $100 million dollar payment in a merger agreement.

Get in Touch




Sharlin Consulting

Joshua Sharlin, PhD

jsharlin@pipeline.com

 

Cell: 410-231-8900

(Washington, D.C.)

 

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