pharmaphorum

SEPTEMBER 30, 2021

Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines. The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

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FDA Documentation Insurance 95

The FDA Law Blog

MAY 6, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. FDA provides examples of changes that are likely and unlikely to impact cybersecurity of an existing device.

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FDA Documentation 105

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. Criteria for regulation.

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FDA Documentation Labelling Communication 105

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. Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. The new § 820.10

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

MARCH 7, 2024

In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes. In another update, the recent draft guidance added “entities reviewing safety data” and adaptation committees.

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FDA Documentation Adverse Reactions Communication 105

European Pharmaceutical Review

NOVEMBER 14, 2023

In the document, it was reasoned that global shortage of these vials threatened the delivery of COVID-19 vaccines and availability of existing parenteral products.

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Packaging Vaccines Documentation FDA 105

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

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

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. filling in a paper-based batch record or analytical result). However, for higher risk data (i.e.,

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Documentation FDA 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

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e., Karst & Steven J.

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FDA Labelling Documentation Communication 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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FDA Documentation Compounding Pharmaceutical Companies 103

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

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FDA Documentation Communication 52

The FDA Law Blog

FEBRUARY 7, 2024

While a DEA registration is not required to sell these products, by definition, any person selling these products is a “regulated person” and all sales of these products are considered “regulated transactions.” 21 U.S.C. § 21 U.S.C. §§ 802(38), (39)(B). 1310.06.

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Controlled Substances Documentation 116

The FDA Law Blog

OCTOBER 26, 2022

Walsh — The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number of practitioners disagree. By Ricardo Carvajal & Anne K.

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FDA Labelling Documentation 59

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

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Documentation FDA 98

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. Quality is a foundation for the development and delivery of pharmaceuticals: per Kopcha’s definition, quality means consistently meeting the expectations of the user.

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FDA Insurance Chemotherapy Documentation 98

The FDA Law Blog

MAY 15, 2023

At the federal level, the Center of Veterinary Medicine (CVM) of FDA regulates food for animals, including livestock and pets. A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. This document also describes an appeal procedure.

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Labelling Documentation FDA 45

The FDA Law Blog

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Valentine & Frank J.

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FDA Documentation Labelling Medical Records 64

The FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.

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FDA Documentation Labelling 61

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Under this definition, a regulatory authority need not adopt in totality any decision reached by another regulatory authority, but they make their own decision.

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FDA Vaccines Documentation Dosage 97

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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FDA Packaging Documentation Labelling 59

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification. 1396r-8(k)(3).

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Vaccines Packaging FDA Documentation 59

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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Documentation FDA Communication Packaging 52

ISPE

NOVEMBER 23, 2022

The final presentation was Regulatory Considerations and Challenges in Development of Cell Therapy Products – CMC Perspective delivered by Dr. Melanie Eacho, Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (OTAT) , US FDA/CBER. CDER/OPQ/OQS/FDA. Christian Woelbeling. Executive Industry Advisor.

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FDA Documentation 52

Impact Pharmaceutical Services

APRIL 27, 2023

Once the designation request has been submitted to the FDA, it is reviewed by the OOPD , which determines if all criteria for ODD approval have been met. Each component of the application must be addressed completely and provide detailed information. The review period is 90 days from time of receipt.

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Documentation FDA 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

The FDA Law Blog

FEBRUARY 27, 2023

The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others. Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications.

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Controlled Substances FDA Documentation Labelling 59

ISPE

JUNE 21, 2023

The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. If It Is Not Documented, It Did Not Happen.

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Documentation Data Entry Compounding FDA 52

The FDA Law Blog

MAY 19, 2023

Collection Device Special Controls Sponsor will need to select a collection device that is either FDA-cleared, -approved, or -classified as 510(k) exempt (either as a standalone collection device or as part of a system) or alternatively the collection device can be cleared within the premarket submission for the POC test.

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Labelling FDA Documentation 40

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Vaccines Compounding Documentation FDA 97

ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

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Documentation FDA Dosage Pharmaceutical Companies 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). Currently, no definitive method for ML software validation has been established by either regulators or industry.

Documentation 52

Documentation Labelling FDA 52

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Under this definition, a regulatory authority need not adopt in totality any decision reached by another regulatory authority, but they make their own decision.

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FDA Vaccines Documentation Dosage 52

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. Concepts of computerized software assurance (CSA) as discussed in the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program 1 are also explored and applied. 1 US Food and Drug Administration. 15 September 2020.

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Documentation FDA Communication 52