pharmaphorum

NOVEMBER 2, 2022

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. In September 2022, the company announced that its therapy, Jogo-Gx, to treat non-specific lower back pain, had achieved statistically significant benefits to patients.

Food and Drug Administration 131

Food and Drug Administration Food FDA Patients 131

MedCity News

JUNE 16, 2023

The consensus is 2022 was a challenging year for digital health companies. billion in 2022 — down 56% from $40.2 billion in 2022 — down 56% from $40.2 Rather, 2022 represents an overdue correction in the midst of global economic uncertainty after a period of overexuberance and lofty expectations in digital health.

Pharma 103

Pharma Food and Drug Administration Recruitment Pharmacology 103

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 112

Medicine Food and Drug Administration Doctors Government 112

European Pharmaceutical Review

APRIL 21, 2023

2022; 6: 949-57. In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs. Lancet Planetary Health.

Pharma 79

Pharma Food and Drug Administration Medicine Pharmaceutical 79

Legacy MEDSearch

MARCH 15, 2023

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

FDA 104

FDA Food and Drug Administration Safety Medicine 104

Clarify Health

NOVEMBER 21, 2022

The original article was published here on November 15, 2022. November 15, 2022 | The movement toward decentralized clinical trials (DCTs) isn’t the only emerging trend that could help bump up clinical trial diversity. Social Determinants Of Health Data Help Identify Sites For Trials. By Deborah Borfitz . Switzerland Platform’ .

Food and Drug Administration 52

Food and Drug Administration Transportation Food Recruitment 52

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness. The FDA’s action plan.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

Clarify Health

NOVEMBER 21, 2022

The original article was published here on November 15, 2022. Social Determinants Of Health Data Help Identify Sites For Trials By Deborah Borfitz November 15, 2022 | The movement toward decentralized clinical trials (DCTs) isn’t the only emerging trend that could help bump up clinical trial diversity.

Food and Drug Administration 40

Food and Drug Administration Transportation Food Recruitment 40

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. ISPE GAMP 5 Second Edition : A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2022.

Manufacturing 82

Manufacturing Pharma Food and Drug Administration Safety 82

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Food and Drug Administration Prescription Media FDA 92

MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence. Nearly 20% of U.S. million increase over 2021.

Food and Drug Administration 87

Food and Drug Administration Prescription Government FDA 87

PM360

AUGUST 9, 2022

Addressing the issue of medication adherence begins before a patient even fills their first prescription. Part of this effort must include a consideration of social determinants of health (SDoH)—food, housing, transportation, access to care, etc.”. Eli Phillips, Jr.,

Food and Drug Administration 105

Food and Drug Administration Prescription Patients Medical 105

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants.

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Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

Food and Drug Administration 52

Food and Drug Administration Prescription FDA Medical 52

Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily.

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FDA Food and Drug Administration Prescription Pharma 52