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June 30, 2022

Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

Summary Company Announcement Date: June 27, 2022 FDA Publish Date: June 30, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Contain Tadalafil Company Name: […]
June 30, 2022

Copiktra (duvelisib): Drug Safety Communication – FDA Warns about Possible Increased Risk of Death and Serious Side Effects

[Posted 06/30/2022] AUDIENCE: Patient, Health Professional, Pharmacy, Oncology  ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra […]
June 30, 2022

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

Copiktra was approved in 2018 based on the benefit-risk evaluation of data available at the time from the DUO trial for patients with relapsed or refractory […]
June 29, 2022

Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

Summary Company Announcement Date: June 28, 2022 FDA Publish Date: June 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect labeling Company Name: […]
June 29, 2022

Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience

Acromegaly EL-PFDD MeetingHost: Acromegaly Community, Inc. Meeting Report January 21, 2021 Acute Porphyrias EL-PFDD MeetingHost: American Porphyria Foundation Meeting Report March 1, 2017 Adrenomyeloneuropathy (AMN) Patient […]
June 29, 2022

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

Submit Comments by 09/29/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
June 29, 2022

Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

Podcast Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this […]
June 28, 2022

We Are Hiring

Are you looking for an exciting and rewarding career in the federal government?  Would you like to make a difference in how prescription drugs, including new […]
June 28, 2022

Scientific Fellowships and Training Programs at CDER

Commissioner’s Fellowship Program The Commissioner’s Fellowship Program affords health care professionals, scientists, and engineers an opportunity to receive regulatory science training and conduct cutting-edge research on targeted […]
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