World of DTC Marketing

FEBRUARY 4, 2021

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. Newly unsealed court documents show that Merck and U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Pharmaceutical Technology

OCTOBER 13, 2022

Melatonin has a prescription-only status and is strictly regulated in the UK, making this the first time it has been approved for use in this indication. Colonis Pharma is a subsidiary company within Clinigen. Prescription-only vs OTC. mg/once daily (one to two hours before bedtime and after food) for up to 13 weeks.

Prescription 59

Prescription Medicine Safety Sales 59

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. We need a 21st-century approach that puts patient safety first. In other words, money over safety. Patients should be scared.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. 1435 (“Affordable Prescriptions for Patients Act of 2021”), [link] gov/bill/117th-congress/senate-bill/1435/text; H.R. Citizen Petitions before the FDA. Actavis, 570 U.S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 82

Manufacturing Pharma Food and Drug Administration Safety 82

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52