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Food and Drug Administration (FDA) › Life Sciences › Risk Assessment

Oberheiden P.C.

Understanding the Risks (and Costs) of Defective Abiomed Impella Heart Pumps

Oberheiden P.C. on

Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more

Arnall Golden Gregory LLP

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

Arnall Golden Gregory LLP on

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

Alston & Bird

FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests...

Alston & Bird on

Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

Quarles & Brady LLP on

The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Hogan Lovells

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

Hogan Lovells on

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Knobbe Martens

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

Hogan Lovells

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader...

Hogan Lovells on

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more

Hogan Lovells

Final guidance provides additional clarity to the Humanitarian Device Exemption program

Hogan Lovells on

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." ...more

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