NOVEMBER 2023 LIFE SCIENCE NEWS
Biden looks to broaden HHS powers to bolster domestic drug manufacturing
“As drug shortages mount in the U.S. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains. Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to safeguard production networks across industries. Chief among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages, according to a White House fact sheet. The move comes as shortfalls of drugs such as amoxicillin, penicillin, Adderall and certain chemotherapies vex doctors and patients across the country. Currently, the FDA lists around 143 drugs as being in shortage on its online database.”
MDCG raises alarm over lack of MDR, IVDR applications
UK launches medicines scheme with £400m earmarked for clinical trials
“The UK Government has signed a deal with the Association of the British Pharmaceutical Industry (ABPI) in a bid to accelerate the country’s clinical trials industry with a £400m investment. The UK’s Department of Health and Social Care has established a new voluntary scheme for branded medicines pricing, access and growth (VPAG), aimed at saving the NHS £14bn ($17.5bn) over five years. The UK Government has said that the deal secures savings for the NHS that would be double those under the current medicine pricing agreement, but also will enable the NHS to increase the speed at which it can adopt new procedures.”
Combination products: Non-harmonized regulations are hurting manufacturers
“Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts who spoke at the 2023 Combination Products Summit held by the AFDO/RAPS Healthcare Products Collaborative. Despite some preliminary efforts at harmonization and good — but thus far unfulfilled —intentions to undertake more substantial changes, the regulatory landscape for these products remains a confusing maze of requirements that often frustrate companies. Although medical products are typically regulated by a country’s primary medical regulatory agency, decisions on combination products are often based on either the therapeutic agent or the device itself, depending on the intended therapeutic action.”
OCTOBER 2023 LIFE SCIENCE NEWS
CDRH Releases List of Proposed 2024 Guidance Documents
“Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming year and asked for stakeholder feedback to be submitted by December 11. Specifically, CDRH is seeking comments on the relative priority of guidance documents on the A-list and B-list (below), as well as proposed policy or information for the FDA to consider for inclusion in these guidances. The agency noted that it also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.”
ICH: Training materials for the Q9(R1) Guideline
The revised guideline includes important supplementary information on the following four areas:
- the subjectivity of risk assessments and QRM results,
- the risks of product availability,
- the lack of understanding of the formality of QRM activities, and
- the lack of clarity in risk-based decision-making.
Experts outline current knowledge on AI and medical devices
With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how its use will impact the medical device industry, experts said at the 2023 RAPS European Clinical and Risk Management Conference. The clinical evaluation of medical devices with AI is an “ever-changing landscape” that regulators will increasingly receive applications for, observed Rachel Mead, clinical regulatory lead at BSI Group. “This is a rapidly expanding field. We’re hearing more and more about how it can bring about transformation in the medical device field in terms of disease prevention, detection and diagnosis,” she added.
In vitro diagnostic device regulation in Europe: Update on revisions
“The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework for in vitro diagnostic (IVD) medical devices to ensure their safety and quality. The enhanced regulatory framework to speed up the market release includes, but is not limited to, additional scrutiny by a notified body, risk classification and conformity assessment, vigilance and market surveillance, and performance evaluation and performance studies.”
SEPTEMBER 2023 LIFE SCIENCE NEWS
MedTech Europe calls for reforms in European medtech regulations
“Together with 34 national associations, MedTech Europe has sent an open letter to Commissioner for Health, Stella Kyriakides, regarding the need for comprehensive structural reform in the European regulatory framework for medical technologies (IVDR and MDR). Representing the medical technology industry across all EU Member States and Switzerland, the 35 organisations emphasise the importance of a fit-for-purpose regulatory system which ensures that medical technologies can reach patients and healthcare systems across Europe in a timely manner. Despite more than six years of implementation, the medical technology regulations IVDR and MDR have not fully achieved their intended objectives.”
Diving into FDA’s QMSR Alignment with ISO 13485
“For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule on harmonization with ISO 13485 last year, and now the reality is settling in that a fully aligned Quality Management System Regulation (QMSR) will soon go into effect. Now companies are asking if they are prepared to meet FDA’s broadened expectations.”
FDA finalizes guidance on real-world evidence in drug approvals
“The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in supporting regulatory decisions for drugs and biologics, offering recommendations for data access and safety monitoring. The guidance, which was released on 30 August 2023, focuses primarily on non-interventional clinical study designs, such as observational cohort studies and case-control studies. However, it outlines what FDA views as potential uses for RWD in interventional studies conducted under an investigational new drug application. For instance, RWD could be used to identify potential participants for a randomized controlled trial, to select endpoints for study, or as a comparator arm in an externally controlled trial.”
FDA issues guidance on using remote oversight tools to help approve drugs
Today, FDA issued new guidance on how the agency intends to use alternative tools in advance or in lieu of an inspection to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process. FDA uses a risk-based approach to determine if alternative tools, including requesting records from manufacturers, remote interactive evaluations of facilities, and receiving information from foreign regulatory partners, may be used. “Today’s guidance will help the agency maintain operational flexibility to support review of drug applications and facility evaluations which could result in timely approval of drugs and facilitate the availability of new, generic, and biosimilar drugs for patients,” said Michael Kopcha, Director of FDA’s Office of Pharmaceutical Quality. “
AUGUST 2023 LIFE SCIENCE NEWS
FDA, DEA Taking Action to Rectify Prescription Stimulants Shortage
“The FDA and DEA recently sent a joint letter to manufacturers of prescription stimulants used in the treatment of conditions, such as attention-deficit/hyperactivity disorder (ADHD), binge eating disorder, and uncontrollable episodes of deep sleep (narcolepsy), to confirm they are working to increase production to meet their allotted quota amount. In the letter, the agencies asked any individual manufacturer that does not wish to increase production to relinquish its remaining 2023 quota allotment, allowing the DEA to redistribute that allotment to manufacturers that will increase production. The agencies cited the lack of availability of prescription stimulants in recent months that has led to frustration for patients and their families as a reason for their decision.”
Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications
“Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time. Over the past year, it became apparent to regulators, NBs, and other stakeholders that there was not enough time for many medical devices to transition from the Medical Device Directive (MDD) to MDR. As a result, transition deadlines were extended earlier this year, but NBs argue that more could be done to prevent potential device shortages in the coming years.”
Medical Device Non-Compliance Is Breaking the Bank
“The risk of being non-compliant in the medical device industry is an expensive proposition. As of Aug. 1, FDA has initiated nearly 30 recalls during 2023 alone, the individual cost of which could top out at more than $600 million. According to the McKinsey Center for Government, an organization that collaborates with many leading global stakeholders to foster the highest levels of device operations, “non-routine” events that are related to quality — such as recalls and lawsuits — will cost the industry between $2.5 billion and $5 billion per year, on average, for the foreseeable future.”
FDA Revises Policies on Obtaining Informed Consent in Clinical Trials
“A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator’s views on informed consent. As FDA explains in the draft guidance, Informed Consent Information Sheet, when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this understanding—while technically correct—is not complete.”
DRAFT GUIDANCE: https://www.fda.gov/media/88915/download
JULY 2023 LIFE SCIENCE NEWS
Pfizer, FDA work to ease shortage concerns as tornado relief efforts pick up at North Carolina injectables plant
“Pfizer and the U.S. FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week. Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage. In the meantime, the site—which Pfizer notes plays a “critical role” in the U.S. healthcare system—will be closed. Most of the damage occurred at the site’s warehouse facility, which stores raw materials, packaging supplies and finished medicines awaiting release by quality assurance, Pfizer said.”
FDA Approves First Nonprescription Daily Oral Contraceptive
“Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. The timeline for availability and price of this nonprescription product is determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only.”
FDA to transition to electronic export documents for devices in 2024
“Starting next year, the US Food and Drug Administration (FDA) will transition key export documents for medical devices from paper to digital format to reduce paperwork and streamline their workflow. Starting 2 January 2024, export documents for human medical devices that are regulated by the Center for Devices and Radiological Health (CDRH) will be issued electronically by FDA as downloadable PDFs from CDRH’s Export Certification Application and Tracking System (CECATS). The agency says the documents may then be validated by foreign governments and other entities who use the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Companies can access the FECV online database from a web address or a QR code on the certificate.”
Regulatory specialist pleads guilty to forging FDA clearance documents
“A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market. According to court documents, Peter Stoll III created counterfeit letters that copied the FDA’s letterhead and the digital signature of an agency official. He said two products developed by his employer Aesculap, a B. Braun company, had received 510(k) clearances—when, in fact, they had never been submitted for review in the first place.”
JUNE 2023 LIFE SCIENCE NEWS
The Future of Industrial AI in Manufacturing: A Manufacturing in 2030 Report
“The growing role and importance of artificial intelligence in manufacturing cannot be overestimated. This pervasive technology, now coming into its own after many years of development and trial and error, is being incorporated into many technologies involved in the manufacturing process, including semiconductors, software applications and platforms, and communications equipment. It is important for the manufacturing industry to understand how AI may shape how factories and plants are run in the years ahead, how it will influence workforce strategies, what business benefits may attend the use of AI and what challenges must be faced and overcome to realize the potential of this technology. At the highest level, a global competition for AI dominance is underway, with manufacturing as a key player in the race. The industry’s competitiveness at home and abroad will be defined increasingly by AI expertise, application and experience—but only in a trusted and responsible way.”
FDA Issues Draft Guidance on Psychedelics
“The FDA published its first draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.1 In the guidance, the FDA says the term psychedelic includes classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).2Psychedelics have been evaluated as therapies for a number of conditions including depression, post-traumatic stress disorder, and substance use disorders. The challenges associated with designing clinical studies to evaluate the safety and effectiveness psychedelics is why FDA issued the guidance.”
Pharmaceutical supply chains raise data concerns as traceability law nears final step
A decade-long regulatory deadline is looming for the pharmaceutical supply chain to electronically share drug data from end to end, or risk healthcare ecosystem instability. Come Nov. 27, if a pharmaceutical manufacturer can’t provide unit-level serialized products to its distributors, no one along the supply chain can legally move it to the next step. If the distributor is unable to provide the pharmacy with electronic tracing data, the pharmacy can’t legally receive the product, or dispense it to the patient. The new rules come as a result of the final implementation stage of the Drug Supply Chain Security Act, or DSCSA, which aims to boost drug traceability and improve patient safety. Companies have been preparing to comply with the law’s various milestones for some time, as it was enacted nearly a decade ago.
FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads
“The US Food and Drug Administration (FDA) has published final guidance on presenting risk and efficacy for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals. The aim of the final guidance is to provide recommendations for companies on how to create advertisements and promotional materials for DTC drug and biologic products with “consumer-friendly” language and presentation, which includes information on presenting probability, formatting quantitative efficacy and risk information, and use of visual aids.”
INDUSTRY NEWS 2022- OUR TOP STORIES!!
QMSR: FDA proposes QSR overhaul after years of delays
“Four years after the US Food and Drug Administration (FDA) signaled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016, the agency on Tuesday issued a proposed rule laying out its vision for the long-awaited regulatory overhaul. The resulting regulation would be dubbed the Quality Management System Regulation (QMSR). According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards. FDA is also proposing to give device makers one year from the publication of the final rule to adapt to the new regulatory requirements.”
Medtech firms warn Government of urgent need for action on EU certification process
“A group representing Ireland’s medical device industry warned the Government that the implementation of new EU rules is running at under capacity. The EU’s Medical Device Regulation (MDR) came into application in May of last year and introduced stricter safety rules for medical devices. It requires device manufacturers to ensure new and existing products are certified under the updated rules. In a letter to Health Minister Stephen Donnelly, the Irish Medtech Association, part of Ibec, said “urgent action” is needed on a European level to prevent shortages of medical devices.”
FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections
“A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools. Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program division director, Division of Pharmaceutical Quality Operations III, Office of Regulatory Affairs…”
UK medical devices law reforms delayed till 2024
“The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimise the risk of supply disruptions for UK patients. The delay means manufacturers whose medical devices have a ‘CE’ marking, which certifies their compliance with EU medical device regulations, will be able to continue placing their devices on the Great Britain market up until 30 June 2024, not 30 June 2023 as previously indicated by the UK government.”
EU issues long-awaited GMP Annex 1 revision
“The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then.”
FDA Lists Mechanisms to Comply With CGMP Requirements for Combination Products
“As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration is finalizing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. While the FDA has provided examples in this notice of the types of mechanisms that may be appropriate, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process. and CP manufacturer.”
FDA Wants More Diversity in Clinical Trials
“The U.S. Food and Drug Administration says companies that produce drugs and other medical products should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday. Though racial and ethnic minorities are affected disproportionately by certain diseases, they are frequently underrepresented in medical research, the FDA said in a news release. Barriers to participation include suspicion of doctors, religion, health illiteracy, and lack of understanding of clinical trials.”
FDA details plans to expand remote safety assessments for device makers
“The FDA wants to keep and expand its ability to remotely conduct safety assessments even after the COVID-19 pandemic. The federal agency recently detailed its plans in new draft guidance for remote regulatory assessments (RRAs) covering all FDA-regulated products. FDA staff started conducting remote assessments when unable to travel due to COVID-19 restrictions, and regulators said RRAs will continue to be valuable beyond the pandemic.”
