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 101

Documentation FDA 101

STAT

OCTOBER 22, 2024

Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. The FDA still has to make a decision on whether to officially place semaglutide on the lists. The agency did not immediately respond to a request for comment.

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Compounding Compounding Pharmacies FDA Documentation 145

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A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.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

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.

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FDA Documentation Vaccines 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 119

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. 

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FDA Documentation 144

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

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Documentation FDA 94

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.

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FDA Documentation 135

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.

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FDA Documentation Hospitals 140

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.

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FDA Documentation 141

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 59

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

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Documentation Method Validation Packaging 98

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.

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FDA Documentation 111

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. |

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FDA Documentation 110

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.

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FDA Documentation Packaging Labelling 105

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

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

Vaccines 111

Vaccines FDA Adverse Reactions Documentation 111

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

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.

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FDA Documentation 125

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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FDA Documentation 133

pharmaphorum

DECEMBER 23, 2021

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The draft is open for comment until 22 March.

FDA 118

FDA Documentation 118

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.

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FDA Documentation Medical Records 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.

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FDA Documentation Insurance 98

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.

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Chemotherapy FDA Documentation 102

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

SEPTEMBER 26, 2023

As a government shutdown looms, FDA published a contingency plan stating it will immediately have to furlough 19% of its staff until it receives more funds. Food and Drug Administration will have to furlough almost one-fifth of its staff and halt work that could have a critical impact on medical-products industries , Regulatory Focus says.

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FDA Documentation 106

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

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FDA Documentation Insurance 123

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

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.

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FDA Documentation 98

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 118

Documentation FDA 118

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” By Holly N. Brevig, Senior Regulatory Device and Biologics Exper & Richard A.

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FDA Documentation 105

pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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FDA Documentation 98

PharmExec

NOVEMBER 7, 2023

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

Documentation 98

Documentation FDA 98

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.

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Documentation FDA 52

STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

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FDA Documentation 105

STAT

SEPTEMBER 29, 2022

One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

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FDA Documentation Hospitals 97