pharmaphorum

JANUARY 25, 2023

The 501(c)3 non-profit Tidepool, which seeks to empower the next generation of innovations in diabetes management, has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old and above.

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FDA Food and Drug Administration Management Physicians 57

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. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Food and Drug Administration Pharma Prescription Manufacturing 52

Legacy MEDSearch

APRIL 12, 2023

Additional development efforts of its proprietary technology platform are underway for tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of growth factors, anti-infective agents, and local anesthetic drugs.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. 1,2 The second occurrence of NDMA arising from degradation was in metformin drug product. Available from: [link] 4. J Pharm Sci.

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Food and Drug Administration Pharmaceutical FDA Medicine 94

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

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Food and Drug Administration Patients Distribution FDA 119

European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy.

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Food and Drug Administration Side effects Manufacturing Doctors 96

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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Patients Food and Drug Administration Medicine Pharma 86

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey as the Senior Principal Scientist in early phase drug development.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 128

Legacy MEDSearch

OCTOBER 11, 2022

Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. Founded in 2013, XACT Robotics® is advancing the field of radiology with cutting edge technology that supports earlier patient diagnosis and treatment.

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FDA Food and Drug Administration Physicians Recruitment 52

Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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Manufacturing Food and Drug Administration Biopharma Sales 52