Regulatory Oversight and Compliance

FDA Interactions with Industry Under Scrutiny

February 02, 2023

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

Proportion, Balance, and Restraint

February 02, 2023

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

Bioequivalence for Immediate-Release Solid Oral Dosage Forms

February 01, 2023

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

FDA Grants Accelerated Approval to Lilly Cancer Drug

February 01, 2023

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA Approves Novel Breast Cancer Treatment

February 01, 2023

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

FDA Resumes In-Person Meetings with Industry … Sort Of

January 31, 2023

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

FDA Releases Research Roadmap for Biosimilars Pilot Program

January 27, 2023

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

January 23, 2023

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Issues Guidance on Development of Drugs for Monkeypox

January 23, 2023

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.