The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover Ozempic?

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Drug Topics

JUNE 11, 2025

READ MORE: FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body The current treatment guidelines for patients with psoriasis include a variety of pharmacological options, such as biologics, phototherapy, and topicals. of the population across the region,” wrote authors of the study.

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Pharmaceutical Technology

JULY 18, 2025

Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.

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FDA Communication Packaging Hospitals 52

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

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Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling 52

The FDA Law Blog

APRIL 14, 2025

Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).

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Documentation FDA 59

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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Documentation Packaging FDA 52

European Pharmaceutical Review

FEBRUARY 28, 2025

1 Following the current trend, there has been a significant rise in the number of documents mentioning both artificial intelligence (AI) and rare diseases. For documents published in 2014 this number was just six; in 2024 it was 157 ( Figure 2 ). 1 Figure 1 : Documents by year. 1 Figure 1 : Documents by year.

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Documentation FDA 88

STAT

JULY 18, 2025

The FDA is set to decide whether to approve the drug, called Blenrep, as soon as next week. market in 2022 after failing a late-stage study. GSK was trying to revive the drug, which was pulled from the U.S.

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Dosage FDA Documentation 58

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

STAT

OCTOBER 20, 2023

The update included 171 new products that use artificial intelligence and machine learning, including 155 authorized since August of 2022. The agency’s data indicate that, after a lull during the Covid-19 pandemic, the number of authorized devices in 2023 is expected to increase by more than 30% over the prior year.

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FDA Documentation 116

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 102

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

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Method Validation Documentation FDA 98

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.

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Documentation FDA 97

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Documentation Communication 105

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 76

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents.

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FDA Documentation Labelling Communication 105

The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

PharmaShots

JUNE 14, 2023

In the year 2022, Roche ranked the top among the Diagnostic Companies with a total revenue of $19.17B followed by GE Healthcare and Siemens Healthineers with $17.72B and $17.64B PharmaShots brings an informative report on the Top 20 Diagnostic Companies Based on the Total Revenue generated in the year 2022 Diagnostic Revenue: $674.7M

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FDA Hospitals Documentation Patient Care 56

ISPE

NOVEMBER 23, 2022

Regulatory Insights from 2022 ISPE Annual Meeting. Wed, 11/23/2022 - 12:32. Regulatory Insights from 2022 ISPE Annual Meeting. 23 November 2022. He closed with a comparison between Canada’s Certified Product Information Document (CPID) and ICH’s Product Lifecycle Management (PLCM) documents. Trudy Patterson.

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Documentation FDA 52

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule closely resembles the proposed rule issued on February 23, 2022. The new § 820.10 Revised § 820.3

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

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FDA Documentation 59

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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FDA Medical Records Documentation 111

ISPE

NOVEMBER 2, 2022

2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. Wed, 11/02/2022 - 10:20. 2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. 2 November 2022. Zimmermann outlined the two main projects of the Board during 2022. Expenses for documents and conferences have been higher this year.

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Documentation Compounding Communication FDA 52

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. There is also encouragement to use tools where possible to increase validation efficiency and defect detection. .

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ISPE

NOVEMBER 23, 2022

Wed, 11/23/2022 - 06:50. 23 November 2022. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. ISPE Represented at PIC/S 50th Anniversary Event. Trudy Patterson. iSpeak Blog. ISPE Represented at PIC/S 50th Anniversary Event.

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Documentation FDA Communication 98

The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). a) , and related guidance documents (e.g., See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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FDA Documentation Labelling 98

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Documentation Labelling 59

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Adverse Reactions Documentation Medical Schools Packaging 96

The FDA Law Blog

FEBRUARY 22, 2023

Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec. FDA did not require HF data as a basis for clearance of the predicate.

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FDA Documentation Labelling Hospitals 64

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1.

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FDA Documentation Labelling Communication 105

ISPE

SEPTEMBER 15, 2022

Thu, 09/15/2022 - 13:50. 15 September 2022. During the 2022 ISPE Pharma 4.0™ Annex 1 Implementation Strategies. Trudy Patterson. iSpeak Blog. Annex 1 Implementation Strategies. Thomas Zimmer, PhD. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history.

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Documentation FDA 97

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. Compliance — Regulators want to see consistent, GDocP-compliant, template-based documentation.

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Documentation FDA 98

The FDA Law Blog

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. For example, FDA granted seven De Novos for COVID-19 related indications for use. In effect, these documents serve as road signs helping to direct new market entrants.

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FDA Documentation Hospitals 69

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Documentation FDA Labelling 52

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

ISPE

SEPTEMBER 12, 2022

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. Mon, 09/12/2022 - 15:18. September / October 2022. 2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. 12 September 2022. 2022 PIC/S Chair, Sr. Rick Friedman.

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FDA Documentation Communication 52