Pharmaceutical Technology

OCTOBER 13, 2022

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). Prescription-only vs OTC. Colonis Pharma is a subsidiary company within Clinigen.

Prescription 59

Prescription Medicine Safety Sales 59

World of DTC Marketing

APRIL 12, 2021

We need a 21st-century approach that puts patient safety first. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety. Supply chain issues in healthcare are damn scary.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. The industry is reaching a tipping point where technologies are coming closer to delivering on its strong promises in improved healthcare for countless patients, helping to dramatically decrease costs across the board.

Side effects 88

Side effects Medical Prescription Patients 88

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. Citizen Petitions before the FDA.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

PM360

AUGUST 9, 2022

According to the 2021 Accenture Healthcare Experience Survey, 52% of patients say having emotional support is important to having a positive healthcare experience. Housing, access to food and transportation, as well as the ability to pay for healthcare and medicine are just a few economic barriers to medical adherence.

Medical 105

Medical Electronics Patients Healthcare 105

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 83

Manufacturing Pharma Food and Drug Administration Safety 83

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information. Drug developers often face a Catch-22 regarding clinical trials and pregnancy.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10