STAT

OCTOBER 20, 2023

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 114

ISPE

MARCH 3, 2023

ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! Trudy Patterson Fri, 03/03/2023 - 13:15 iSpeak Blog iSpeak ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! Link them through a TM, otherwise the FDA will give you a 483!”

Documentation 98

Documentation FDA 98

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Documentation FDA 64

The FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Timeline Section 524B became effective on March 29, 2023.

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FDA Documentation Labelling Communication 105

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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FDA Documentation 59

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

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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Documentation FDA 119

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.

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FDA Documentation Compounding 105

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 ). Any comments to the public notice must be submitted by August 11, 2023.

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FDA Documentation Labelling Communication 59

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. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.

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FDA Documentation Labelling 59

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. FDA further retained some definitions in the QSMR. The new § 820.10 Revised § 820.3

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FDA Labelling Packaging Documentation 59

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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FDA Research Laboratories Documentation 69

IDStewardship

MARCH 12, 2023

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

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Medication Guidelines Documentation Labelling Hospitals 299

The FDA Law Blog

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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Documentation FDA 88

The FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. Several weeks later, also based on ability to pay, the U.S. Consent Agreement and Final Judgment ¶ 17.

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Controlled Substances Documentation Prescription Filling Dosage 139

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

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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FDA Compounding Pharmacies Labelling Compounding 59

The FDA Law Blog

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). This would align with the timeline in the Unified Agenda which identifies December 2023 as the expected publication date for the final rule.

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FDA Documentation Labelling 52

The FDA Law Blog

MARCH 27, 2023

FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. See 21 CFR 801.40(d). Emphasis added.)

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Labelling Packaging FDA Documentation 45

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

ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

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Documentation FDA 98

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

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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Insurance Insurance Coverage FDA Documentation 104

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

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

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. However, for higher risk data (i.e., This would satisfy the requirement under PICS section 8.11

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Documentation FDA 98

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

European Pharmaceutical Review

JULY 10, 2023

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. Evaluation of Ames assay test conditions for N -nitrosamines is ongoing, with a goal to identify the most robust Ames testing conditions, EMA reported in the revision document.

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Documentation FDA 98

Pharmafile

JANUARY 5, 2023

It is possible that Island Pharmaceuticals could begin its phase 2a PEACH clinical trial as soon as January 2023. The company is in the process of finalising its Investigational New Drug (IND) application to the FDA which will allow this trial to begin. The trial aims to assess its dengue prevention and treatment drug, ISLA-101.

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Documentation FDA 52

ISPE

NOVEMBER 23, 2022

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

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Documentation FDA Communication 98

pharmaphorum

JULY 16, 2021

Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after FDA advisors voted comprehensively against the drug yesterday.

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FDA Documentation 52

The 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.

Documentation 52

Documentation FDA 52

The Checkup by Singlecare

JUNE 6, 2025

A meta-analysis published in 2023 found that semaglutide was safe and effective for the treatment of NAFLD. Most major insurance plans, including some plans from United Healthcare and Blue Cross Blue Shield , cover Ozempic for its FDA-approved uses, such as for the treatment of Type 2 diabetes.

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Insurance FDA Health Insurance Companies Labelling 52

The FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. The final rule will be effective February 21, 2023.

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FDA Documentation 52

Pharmaceutical Technology

APRIL 13, 2023

Projections for 2023 Digitalisation is key moving forward Fully utilising digitalisation as part of a DCT can result in savings in both time and costs. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

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Documentation Communication FDA 52

The FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. FDA has begun to reintroduce in-person meetings. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023. However, not all changes are forever.

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FDA Communication Documentation 53