FDA Law Blog

FEBRUARY 20, 2023

Among its services are prescription drug discounts, telehealth visits, and other health services. This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. It may be that cases like this one may affect future FDA data cases.

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XTalks

MAY 21, 2024

This year’s event was particularly momentous, with a noteworthy announcement from the US Food and Drug Administration (FDA) about the extensive ongoing efforts to innovate clinical trials. The FDA’s message emphasized the crucial advancements in science and technology that are propelling medicine forward.

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FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

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FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). Javitt & Allyson B.

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XTalks

SEPTEMBER 9, 2022

This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode.

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FDA Law Blog

NOVEMBER 21, 2022

Food & Drug Admin., One cause of death in this “valley” is related to the need to understand and meet regulator expectations. Food & Drug Admin., Devices regulated by the Center for Biologics Evaluation and Research (CBER) and combination products are outside the scope of the TAP Pilot. By Adrienne R.

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XTalks

OCTOBER 26, 2022

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has moved forward with a plan to minimize the risks of breakthrough medical devices by introducing its voluntary Total Product Life Cycle Advisory Program (TAP) Pilot.

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Cloudbyz

JULY 31, 2024

The Principal Investigator (PI) of any study, be it drug or device, has many responsibilities, including ensuring regulatory compliance, overseeing the conduct of the study, and safeguarding the well-being of study participants. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.

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XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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XTalks

APRIL 6, 2021

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. for the next public health emergency.”.

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XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 CPAP machines used to treat or manage obstructive sleep apnea. Addressing these safety concerns remains a top priority for the FDA.”

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pharmaphorum

DECEMBER 11, 2022

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. Digital transformation in pharma is not a singular endeavour. This is a growing area and one that Hadjiat said was a focus of the team at Frontiers Health.

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The Pharma Data

MAY 5, 2021

A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward. . In the first half of that 12-month period, inspections related to human drugs, devices and biologics numbered 51, 30 and 22, respectively.

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FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.

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The Pharma Data

APRIL 20, 2022

Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). director of the FDA’s Center for Devices and Radiological Health.

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Delveinsight

SEPTEMBER 2, 2021

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.

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The Pharma Data

NOVEMBER 17, 2020

Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. director of FDA’s Center for Devices and Radiological Health. Food and Drug Administration. SILVER SPRING, Md. , .

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The Pharma Data

NOVEMBER 12, 2021

Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. Source link: [link].

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The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

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FDA Law Blog

OCTOBER 10, 2022

The final CDS Guidance represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be Non-Device CDS or low-risk Device CDS under enforcement discretion.

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Advarra

APRIL 30, 2024

For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. In some countries, local regulations may indicate the sub-investigators need to sign as well. Remember, some staff may not need protocol-specific training.

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The Pharma Data

OCTOBER 14, 2020

Udelson, MD is Chief of the Division of Cardiology at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine. Previously, he was Chief of the Heart Failure Section at Duke University School of Medicine from 2013 to 2020. About Dr. Udelson James E. Source link.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

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XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union.

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pharmaphorum

MARCH 16, 2021

By using AI we can extract all the information – including symptoms, signs and drug prescription outcomes throughout the patient journey.”. It’s a statistical model, which by design, guarantees confidentiality and satisfies the requirements of Hospital ethics committees, NHS regulations and Life Science industry policies.

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FDA Law Blog

NOVEMBER 6, 2024

Koblitz — The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Congress was “plainly [ ] aware” of FDA’s definition of “same drug” when it revised the Orphan Drug Act in 2017, which is “evidence that Congress intended to ratify the regulatory definition of ‘same drug’ in § 360cc(a).”

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

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The Pharma Data

MAY 3, 2021

Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). Amgen’s KRAS cancer drug had a bad week, but worry about pricing, not safety ( STAT ). Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ).

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XTalks

SEPTEMBER 14, 2020

Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. percent in 2021.

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FDA Law Blog

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA).

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