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. It applies whether the software is the entire device (i.e.,

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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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The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. FDA has begun to reintroduce in-person meetings. It is also noteworthy that in the March 27 announcement , FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g., However, not all changes are forever.

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The FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). As part of the pilot program, FDA included a Test Plan. By Adrienne R.

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The FDA Law Blog

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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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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The Checkup by Singlecare

APRIL 5, 2024

That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Foxman recommends that every patient review their formulary to see how Ozempic is covered and communicate directly with their insurer for clarity on the specific requirements. “It’s

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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The FDA Law Blog

NOVEMBER 15, 2022

User fees are fees that FDA collects from “companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.” These fees supplement the annual funding Congress provides for FDA. These fees are negotiated by FDA and industry every five years.

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ISPE

NOVEMBER 23, 2022

Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Build PIC/S operational capacity by securing new revenue streams, implementing fiscally sound financial plans and increase transparency to the PIC/S community.

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The FDA Law Blog

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

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DiversifyRx

NOVEMBER 24, 2023

This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. When regulators, such as the FDA, request information about a specific drug product, your pharmacy must be able to promptly provide the necessary traceability data. The DSCSA aims to streamline this recall process.

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ISPE

NOVEMBER 3, 2022

The regulatory keynote was delivered by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), US FDA. Marks outlined some concepts that the FDA is thinking about that could help move in this direction, such as developing a “cookbook” to standardize bespoke product development and manufacturing.

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The FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. Other communications may suffice to show infringement, but carved-out labeling more accurately reflects an intent not to encourage infringement, reasons the Government, extensively citing Judge Prost’s Federal Circuit dissent. GSK skinny label case , the U.S.

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Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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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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The Checkup by Singlecare

DECEMBER 26, 2023

Yes, as of March 2020 , insulin is considered a biologic product by the FDA. Regulatory bodies such as the FDA conduct thorough tests to confirm that they meet safety, purity, and potency standards. The FDA Purple Book database can be a good resource to determine whether a biologic drug is interchangeable.

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European Pharmaceutical Review

JULY 4, 2023

There are also numerous industry guidance documents for products manufactured for use in clinical trials and guidelines, some which are specific to advanced therapeutic drug products that must be consulted. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

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Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US. Nevertheless, it is incumbent on trialists to communicate such changes.

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European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Good documentation practices. Joseph S Boakai (JSB): The three current trends are as follows: Increased scrutiny by regulatory bodies.

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pharmaphorum

JANUARY 4, 2022

They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

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The FDA Law Blog

DECEMBER 12, 2022

Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. During the COVID-19 pandemic, the US FDA issued guidelines for remote evaluations of drug manufacturing and bioresearch facilities. Audio-visual communication. Text communication.

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ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.

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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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The Checkup by Singlecare

MAY 1, 2024

The FDA has approved these devices for mild to moderate hearing loss. Necessary documentation and information Financial assistance programs may require proof of income. Other documentation they may require includes: Identification (driver’s license, passport, etc.)

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ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

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The FDA Law Blog

FEBRUARY 27, 2023

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. The only schedule III-V narcotic drug that is currently approved by the FDA for OUD treatment is buprenorphine.

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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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The Checkup by Singlecare

OCTOBER 17, 2023

Although this infection has been documented with almost all antibiotics, the most frequent offenders include clindamycin , ampicillin, amoxicillin, and cephalosporins. To ensure safe drug management, people should communicate openly with their healthcare providers about all medical conditions , medications, and supplements.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Wireless medical devices.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Wireless medical devices.

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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. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”

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The FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. Several sections of the eSTAR templates have questions that walk through related guidance documents. By Adrienne R. Know Your Guidances.

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The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

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