The FDA Law Blog

JULY 7, 2025

By Véronique Li, Senior Medical Device Regulation Expert — In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable. This editorial change began in December 2019 to indicate that the document amends the Code of Federal Regulations.

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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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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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The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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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 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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The FDA Law Blog

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

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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

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.

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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

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

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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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ISPE

SEPTEMBER 15, 2022

The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments. 12 of February 2020 again received 2,000 comments from public consultation.

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Documentation FDA 97

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. Phillips Professional Achievement Award in 2017 , an award that honors an ISPE Member’s significant lifetime contribution to the industry, not just ISPE.

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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? 3 Is two too few?

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% However, the FDA's approval of Lumakras for metastatic non-small cell lung cancer in May last year has a global analyst consensus sales forecast of $336m for this year, according to GlobalData’s Drugs Database. Amgen reported only a marginal 2.2% YoY revenue growth to $26.0bn last year.

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pharmaphorum

DECEMBER 28, 2022

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. She joined NSF in 2017. Preparing for acquisition means preparing for this due diligence investigation to maximise your value and attractiveness.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. However, not all accelerated approvals for Keytruda have been successfully converted into full approvals.

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pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

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ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

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The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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pharmaphorum

DECEMBER 6, 2022

We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017.

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ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Problem Identification. Root Cause Identification.

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Impact Pharmaceutical Services

APRIL 27, 2023

In addition, the OPEN Act, introduced in 2017, can extend the exclusivity period of a previously approved drug by another six months. 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.

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The Checkup by Singlecare

OCTOBER 9, 2024

Dupixent (dupilumab) is a brand-name monoclonal antibody drug that is approved by the Food and Drug Administration (FDA) to treat a variety of conditions. Its first approval was in 2017 for atopic dermatitis (eczema). Most only issue coverage for treatments approved by the FDA.

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Pharmaceutical Technology

JUNE 30, 2022

In 2017 Oximio began providing dedicated local clinical trial support from its depot in Tbilisi as well as its courier fleet. Global inflation and the increased cost of petrol are also influencing the cost of multinational airfreight, making shipments from the EU and US more expensive than a distribution from a local depot. Expert partners.

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The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

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PharmaShots

JUNE 14, 2023

In Sep 2022, Konica’s Chiropractic Straight Arm (CSA) system received the US FDA’s approval as an X-ray technology allowing diagnosis through visualization of the anatomy. In Jul 2022, DiaSorin’s Liaison MeMed BV test received the US FDA’s approval for its commercial launch across the US.

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ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Published 19 January 2017. 30 June 2016. link] 6 BBC News. link] 7 He, J., Cai, and X.

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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). These media fill process simulations also serve to evaluate the aseptic technique used during operator interventions.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2017. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel.

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ISPE

JANUARY 11, 2023

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. 11 (2017): 36–46.

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ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? 2 (2017): 44–46. m/s up to 0.54

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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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