Setter: A FOIA Getter

The 270 MDR reports mentioned in the 11/28/23 FDA Safety letter on Phillips Respironics Dreamstation 2 thermal issues. https://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication?utm_medium=email&utm_source=govdelivery

Requester: Allinace of Sleep Apnea Partners

I am seeking communications between Neuralink and the following FDA officials/contractors: William Maisel Owen Faris Angela Krueger David McMullen Julia Slocomb Vivek Pinto Heather Dean Gabriela Suarez-Mier I am also seeking emails, notes, word documents, phone logs, meeting notes, and calendar entries generated by or…

Requester: Bloomberg News

This request seeks the tentative (where applicable) and final approval routing summaries for ANDA No. 076800, filed by Ranbaxy Laboratories, Inc., and ANDA No. 076799, filed by Alphapharm Pty. Ltd.

Requester: Wexler Boley & Elgersma

All documents related to "pulse oximeter" and "skin pigmentation" including presentations, email correspondence, medical device approval records, PMAs, 510Ks, and De Novo Classifications. I request that you release this on a rolling basis as records become available.

Requester: ASSOCIATED PRESS

I am a reporter and fellow in MIT's Knight Science Journalism Program, which includes reporting for MIT Technology Review. Paul Richards, an FDA communications representative, advised me to file this FOIA request, which I'm seeking to be expedited as a member of the news media reporting in real time. For my reporting,…

Requester: MIT Knight Science Journalism Program

CONGRESSIONAL CORR RE INFANT FORMULA OUTBREAK 3/1/22 TO PRESENT

Requester: Agri-Pulse Communications, Inc.

All correspondence between the FDA and the individual, Joseph M. Mercola, DO and his associated business entities including but not limited to: Optimal Wellness Center, Dr. Mercola’s Natural Health Center, Thermography Diagnostics Centers, Mercola.com LLC, Mercola.com Health Resources, LLC. etc

Requester: THE NEW YORK TIMES

All records, emails, correspondence, reports and data related to the recall and investigation of Aziyo Biolgics, Inc.'s single donor lot of its FiberCell Viable Bone Matrix that occurred on/about June 2, 2021. Any available clinical or treatment data of patients affected by the contaminated product is also requested. …

Requester: THOMAS JEFFERSON UNIVERSITY HOSPITAL, INC.

Copies of any and all correspondence, adverse event reports, and other records related to the June 2, 2021 recall of FiberCel Fiber Viable Bone Matrix Donor Lot Number NMDS210011, manufactured by Aziyo Biologics, Inc. (see attached request letter).

Requester: Levin Papantonio Rafferty et al

Pfizer and Moderna Vaccine recs

Requester: Shayna Pitre - Be It Crew, L3C

RECS RE COVID 19 MISINFORMATION ETC

Requester: Gene Hamilton - America First Legal Foundation

Any documents referenced or relied upon by the FDA in its letter, dated June 16, 2020, to Chembio Diagnostic Systems, Inc. (“Chembio”) (the “June 16, 2020 letter”). The documents I request which are referenced in the June 16, 2020 letter include the following: (1) the April 29, 2020 and May 15, 2020 data submitted by …

Requester: Rolnick Kramer Sadighi LLP

Any documentation concerning any regulatory meeting between Dr. Reddy’s Laboratories Limited (hereinafter “DRL”) and the FDA on or before January 17, 2018, concerning CTO Unit VI, located at APIIC Industrial Estate, Pydibhimavarma (Village), Ranasthalam Mandai, Srikakulam District – 532-409, Andhra Pradesh (hereinafte…

Requester: Lewis Brisbois Bisgaard & Smith

Emails between Peter Marks and Francis Collins

Requester: ProPublica

All correspondence among FDA staff, cosmetics manufacturers, public health officials, consumer groups, lawmakers, and/or their representatives, regarding health concerns about keratin-based hair-straightening/hair-smoothing products and/or their formaldehyde content and/or formaldehyde released from these products fro…

Requester: ENVIRONMENTAL WORKING GROUP

ALL DIRECTIVES, ORDERS, OR GUIDANCE FROM THE WHITE HOUSE RE ISSUANCE OF EMERGENCY USE AUTHORIZATIONS FOR CORONAVIRUS MEDICAL EQUIPMENT

Requester: American Oversight

Submissions and communications between the FDA and Medtronic related to the agency's safety alert issued 6/27/2019 related to cybersecurity vulnerabilities in Medtronic insulin pumps, including any emails and responses to or from Medtronic staff and agency officials.

Requester: FierceMedTech

All documents, reports, studies, memos, articles or other materials from 1986 to current day used to determine that vaccines are "safe and effective" with saline placebos in control groups in the animal studies

Requester: Moms Across America

The original applicant of PMA devices between 1976 and 2018 and any updated histories of the applicant - see attached

Requester: UNIVERSITY OF MINNESOTA

SAMPLE RECS

Requester: Imprimis Pharmaceuticals, Inc.

P030053 APPROVAL LARGE STUDY, 27 REPORTS FROM THE OSB LEAD LARGE PAS SCHEDULE

Requester: Sara Ebrahimi

REPLAGAL - RECS RE EXPANDED ACCESS, COMPASSIONATE USE 06/16/2009 - 03/01/2012

Requester: Misha Angrist, PhD

REPLAGAL - BRIEFING MATERIALS, CORR

Requester: Misha Angrist - Misha Angrist, PhD