STAT

OCTOBER 27, 2023

None of the concerns raised by the FDA on Friday, however, suggest the agency is reluctant to approve the treatment, called exa-cel, which is being developed by Vertex Pharmaceuticals and CRISPR Therapeutics.

Documentation 141

Documentation FDA 141

BioPharm

JULY 25, 2024

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

Documentation 52

Documentation FDA 52

BioPharm

MAY 3, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Documentation 111

Documentation FDA 111

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

Documentation 59

Documentation Labelling FDA Packaging 59

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. For the first time, the FDA has explained in copious detail why agency officials believe the medication, which is called Makena, should be removed.

Documentation 99

Documentation FDA 99

Fierce Pharma

SEPTEMBER 11, 2024

Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming.

FDA 91

FDA Documentation 91

Pharmafile

JANUARY 20, 2023

India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022. read more

Documentation 94

Documentation FDA 94

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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FDA Documentation 98

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation FDA 69

STAT

JUNE 20, 2024

On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. 

FDA 142

FDA Documentation 142

STAT

JUNE 25, 2024

The company also received FDA clearance for KAI 12L, the software that can analyze ECGs to detect up to 35 conditions including arrhythmias, like atrial fibrillation, and other issues, like heart attacks.

FDA 137

FDA Documentation Hospitals 137

Fierce Pharma

JUNE 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

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FDA Documentation 97

BioPharm

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 59

Documentation FDA 59

The FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

FDA 111

FDA Communication Documentation 111

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

FDA 133

FDA Documentation Vaccines 133

Fierce Pharma

OCTOBER 3, 2023

As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead. |

FDA 86

FDA Documentation 86

STAT

SEPTEMBER 10, 2024

Seven years after the FDA approved Luxterna , scientists have yet to bring another congenital blindness treatment to the market. The group recently published a study in The Lancet documenting their success using gene therapy to treat an inherited retinal blindness that affects as many as 100,000 people globally.

Documentation 111

Documentation FDA 111

BioPharm

JANUARY 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Documentation 40

Documentation FDA 40

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 135

FDA Documentation 135

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 98

Vaccines Documentation FDA 98

STAT

SEPTEMBER 25, 2023

BrainStorm filed for approval over the FDA’s protest, insisting that NurOwn has demonstrated benefits for a subset of ALS patients with milder disease.

FDA 136

FDA Documentation 136

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105

FDA Documentation Packaging Labelling 105

The FDA Law Blog

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different.

FDA 105

FDA Documentation Medical Records 105

BioPharm

JUNE 27, 2024

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Documentation 52

Documentation FDA 52

The FDA Law Blog

SEPTEMBER 12, 2024

Walsh — While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified as voluntary or official action indicated (VAI or OAI).

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FDA Documentation 59

The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

FDA 59

FDA Documentation Labelling Communication 59

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. c) a submission of an IDE to the FDA is not required. c) a submission of an IDE to the FDA is not required.

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FDA Documentation 105

STAT

JUNE 8, 2023

” FDA staff said that data from a late-stage trial of Eisai and Biogen’s Alzheimer’s drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval , Reuters reports. The FDA decision is expected by July 6.

FDA 97

FDA Documentation Insurance 97

STAT

JULY 31, 2024

Mount Sinai researchers had claimed, in a patient consent form and in documents submitted to the FDA and the National Institutes of Health, that patients in the study do not lose any additional tissue than they would during standard DBS, a procedure used to ease the symptoms of certain neurological conditions.

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Documentation FDA Hospitals 145

STAT

OCTOBER 20, 2023

The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness.

FDA 117

FDA Documentation 117

STAT

JUNE 6, 2023

Notably, the FDA inspectors found a truck that was waiting for clearance to leave the facility and was carrying plastic bags that contained shredded documents. The inspectors found issues with data integrity and procedures designed to prevent microbiological contamination, among other problems.

Chemotherapy 100

Chemotherapy FDA Documentation 100

BioPharm

JUNE 21, 2024

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.

Documentation 52

Documentation FDA 52

pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

FDA 59

FDA Documentation Labelling 59

The FDA Law Blog

SEPTEMBER 11, 2024

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. FDA starts by setting the limit of what it views as acceptable intake (AI) limits, so that manufacturers and applicants can know what targets they should hit. By John W.M.

FDA 105

FDA Documentation Compounding 105

PharmExec

NOVEMBER 7, 2023

House Committee on Oversight and Accountability request documents on agency’s drug shortage mitigation strategies.

Documentation 98

Documentation FDA 98

STAT

SEPTEMBER 16, 2024

They dug into a decade of documents from the Food and Drug Administration to understand how devices recalled for their risk of serious injury or death were clinically tested before being used on patients.    In most cases, they simply weren’t.

Documentation 121

Documentation FDA 121

STAT

JANUARY 3, 2023

A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Aduhelm, the first new drug for Alzheimer’s disease in two decades.

FDA 98

FDA Documentation 98