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Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food & Drug Administration

PR-M03-22-03Mar 07, 2022

Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation

Thomas Briel, Ph.D.; Moritz Beck-Broichsitter, Ph.D.

MilliporeSigma

PA141Jan 28, 2022

Process Development

Designing More Sustainable Small Molecule API Manufacturing Processes

Marko Salo; Arne Grumann

Fermion

PAO-09-21-CL-05Sep 16, 2021

Fecal Transplant

Fecal Transplant Associated with One Patient Death

David Alvaro, Ph.D.

Pharma's Almanac

PAO-M06-19-NI-020Jun 21, 2019

FDA Action

FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices

U.S. Food & Drug Administration

PR-M04-19-NI-060Apr 18, 2019

Safety Labeling

FDA Orders Important Safety Labeling Changes for Addyi

U.S. Food & Drug Administration

PR-M04-19-NI-045Apr 15, 2019

FDA

Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines

U.S. Food & Drug Administration

PR-M04-19-NI-035Apr 10, 2019

Public Health

FDA and CBP Bolster Collaboration to Protect Public Health and Safety

U.S. Food & Drug Administration

PR-M04-19-NI-034Apr 10, 2019

Stem Cells

Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development

U.S. Food & Drug Administration

PR-M04-19-NI-031Apr 09, 2019

Drug Safety

BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses

BioIVT

PR-M03-19-NI-024Mar 08, 2019

Safety

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food & Drug Administration

Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation

Thomas Briel, Ph.D.; Moritz Beck-Broichsitter, Ph.D.

MilliporeSigma

Process Development

Designing More Sustainable Small Molecule API Manufacturing Processes

Marko Salo; Arne Grumann

Fermion

Fecal Transplant

Fecal Transplant Associated with One Patient Death

David Alvaro, Ph.D.

Pharma's Almanac

FDA Action

FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices

U.S. Food & Drug Administration

Safety Labeling

FDA Orders Important Safety Labeling Changes for Addyi

U.S. Food & Drug Administration

FDA

Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines

U.S. Food & Drug Administration

Public Health

FDA and CBP Bolster Collaboration to Protect Public Health and Safety

U.S. Food & Drug Administration

Stem Cells

Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development

U.S. Food & Drug Administration

Drug Safety

BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses

BioIVT

Quality Metrics

FDA Makes More Quality Moves

Nigel Walker

Nice Insight

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food & Drug Administration

Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation

Thomas Briel, Ph.D.; Moritz Beck-Broichsitter, Ph.D.

MilliporeSigma

Process Development

Designing More Sustainable Small Molecule API Manufacturing Processes

Marko Salo; Arne Grumann

Fermion

Fecal Transplant

Fecal Transplant Associated with One Patient Death

David Alvaro, Ph.D.

Pharma's Almanac

FDA Action

FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices

U.S. Food & Drug Administration

Safety Labeling

FDA Orders Important Safety Labeling Changes for Addyi

U.S. Food & Drug Administration

FDA

Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines

U.S. Food & Drug Administration

Public Health

FDA and CBP Bolster Collaboration to Protect Public Health and Safety

U.S. Food & Drug Administration

Stem Cells

Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development

U.S. Food & Drug Administration

Drug Safety

BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses

BioIVT

Quality Metrics

FDA Makes More Quality Moves

Nigel Walker

Nice Insight