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

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

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 108

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 130

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 134

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

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

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Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something.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

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.

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Documentation FDA 40

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

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 114

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 97

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 99

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 96

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 99

Chemotherapy FDA Documentation 99

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 ).

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FDA Documentation Labelling Communication 59

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 111

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 101

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

PharmExec

NOVEMBER 7, 2023

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

Documentation 98

Documentation FDA 98

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

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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FDA Documentation Packaging Communication 75

STAT

JUNE 9, 2023

At the meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit. In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Track the meeting here and here.

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FDA Documentation Vaccines 89

BioPharm

MARCH 7, 2024

The agency has published final guidance documents regarding validation and development of analytical procedures.

Documentation 52

Documentation FDA 52

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

The FDA Law Blog

FEBRUARY 6, 2024

PM Counsel John Claud to testify yesterday about FDA’s foreign inspection program. We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. FDA was invited to attend but did not.

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FDA Documentation 52

Pharmafile

MARCH 21, 2023

It appears that the FDA is inclined to support Biogen’s amyotrophic lateral sclerosis (ALS) drug, tofersen, with documents released on Monday stressing the need for “regulatory flexibility” when assessing treatments for life threatening diseases such as ALS. read more

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FDA Documentation Communication 59

The FDA Law Blog

OCTOBER 26, 2023

Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. FDA uses this program to help it identify risks and to determine whether further investigation is needed. 552), there are exemptions from mandatory disclosure.

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FDA Documentation 52

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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FDA Documentation Communication 45

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.

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Vaccines FDA Adverse Reactions Documentation 111

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

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

The FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

Documentation 97

Documentation FDA 97

STAT

JUNE 16, 2023

One facility shut down after the FDA found shredded documents about quality, indicating serious lapses and raising doubts about safety and efficacy of its drugs. FDA inspectors visited another plant in May and found problems with “safety, efficacy, purity and overall quality of drug products manufactured” at the facility.

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FDA Documentation 93

BioPharm

DECEMBER 21, 2023

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

Documentation 52

Documentation FDA 52

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 95

BioPharm

DECEMBER 21, 2023

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

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Documentation FDA 59