The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on their performance criteria rather than by comparison to a predicate device.   “FDA recognizes that in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics than ...

The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality System Regulation (QSR) with international standard ISO 13485:2016. Despite that deadline being roughly eight months away, it’s never too early for industry to prep for its arrival, two longtime experts say.   The FDA released its draft Quality Management System Regulation (QMSR) in February 2022; the agency had ...

In Focus: US Vaccine Decisions: US FDA And CDC Weigh New Vaccines For Diseases From Dengue To RSV ( Pink Sheet ) U.S. FDA panel to discuss Perrigo’s daily OTC birth-control bill in May ( Reuters ) At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion ( Pink Sheet ) Drug Supply Chain is Vulnerable to Threats, Says Senate Committee ( FDAnews ) FDA Generics Program Resumes In-Person Meetings ( FDAnews ) Neonatal Drug Development Could Bene...

The Drug Regulatory Authority of Pakistan (DRAP) has released for consultation draft guidelines on good cold chain management practices for temperature-sensitive drug products. DRAP created the text to set out the principal requirements for the safe storage and distribution of cold chain medicines.   When finalized, the 43-page document will serve as DRAP’s first dedicated guidelines on shipping time- and temperature-sensitive pharmaceutical drug products (TTSDPs). The...

BASEL, Switzerland – Two International Council on Harmonization (ICH) guidelines covering stability testing and specification setting are undergoing long-overdue revisions and are expected to be “substantially” revised said an industry official at DIA Europe 2023.   Updates on the ICH Q1A-Q1F suite of guidelines on stability testing and the Q6A and Q6B guidelines on setting specifications were prompted by members of the ICH Quality Discussion Group (QDG), which identif...

The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to traditionally marketed products – but it hasn’t budged on the 180-day transition timeline.   On 24 March, the FDA Center for Devices and Radiological Health (CDRH) published two final guidances for transitioning medical devices and diagnostics that have been temporarily allowed on the market due to t...

Francisco Rossi, director of Colombia’s National Food and Drug Surveillance Institute (INVIMA) since September 2022, is leaving the agency and will be replaced by Mariela Pardo Corredor, the Colombia Ministry of Health and Social Protection announced on 23 March. Rossi’s departure comes amid heated legislative debates about ongoing medication shortages in the country and the role of the regulatory agency in addressing them. Rossi had been a top proponent, along with his...

In Focus: US Under protest, FDA to convene advisory panel to review controversial cell therapy for ALS ( STAT ) ( BioPharma Dive ) Pharming’s Leniolisib Gains FDA Approval in Ultra-Rare Disease ( BioSpace ) Indian generic drugmaker to launch Leo Pharma copycat drug in US ( MedWatch ) Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza ( Pink Sheet ) iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Cou...

The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs) – rather than single-arm studies -- the “preferred approach” to support accelerated approval.  Sponsors can conduct a single RCT to support accelerated approval and verify clinical benefit or run two trials, one that supports accelerated approval through the use of an early endpoint and one confirmatory tr...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. It’s been a busy week for the agency as Xavier Becerra, secretary of the US Department of Health and Human Services, defended his department’s proposed FY2024 budget in the Senate, the FDA released several guidances and reports, and announced upcoming meetings.   During a Senate Fin...

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.   As part of FDA’s commitment under the Prescription Drug User...

BASEL, Switzerland – In a pandemic-like situation, the European Medicines Agency (EMA) should reserve resource-intensive activities for promising medicines and should reinforce its cooperation with partners such as the EU National Immunization Technical Advisory Groups (NITAGs). That’s according to the agency’s Melanie Carr, who spoke at DIA Europe 2023 on some of the knowledge EMA gleaned from the COVID-19 pandemic.   Carr, head of stakeholders and communications divi...