Harvard to open new lab space named after Celtics co-owner
On Thursday, Harvard University will open a 15,000-square-foot life science lab in Allston named after Steve Pagliuca, and executive at Bain Capital and co-owner of the Boston Celtics. The Pagliuca Harvard Life Lab will be the home to 20 startup ventures founded and run by Harvard faculty, alumni, students, and postdocs. The first 17 of those were revealed by the university a couple weeks ago, and they include drug and vaccine developers as well as DNA sequencing companies. Mayor Marty Walsh will…
Trial suggests Flexion’s knee injection may be safer for diabetes patients
The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…
Shire quietly halts new investments coming out of Baxalta Ventures
Today, Shire plc confirmed it won’t make any new investments from Baxalta Ventures, the short-lived venture capital arm of the drug company Shire acquired in June.
Venture firm Third Rock raises $616M fund, names female partner
Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…
FDA approval delayed for Sanofi Genzyme’s next blockbuster
Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…
Medtech startups to pitch investors at annual MassMEDIC Showcase
On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…
Ra makes nine Mass. biotech IPOs, over $640M raised, this year
Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million…
Vertex boosts market cap on plan for cystic fibrosis 'triple combo'
Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…
Nursing home pharmacy to pay $476K settlement to Mass. after kickback charges
The nation’s largest pharmacy serving elder care facilities will pay Massachusetts nearly half a million dollars to settle allegations that it got kickbacks more than eight years ago from Abbott Laboratories to promote the anti-seizure drug, Depakote. The settlement was signed by Omnicare, a pharmacy services company that was acquired by CVS Health Corporation (NYSE: CVS) in August 2015. The $476,216 payment to Massachusetts is part of a $28 million multi-state settlement that included 47 states…
Philly-based gene therapy firm teams up with UMass Medical researcher
Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…
RE: Online sale of unapproved combinations of Minoxidil as topical solution
From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations. Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it. Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug. Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]
RE: UV Light Sterilizers
From : Communities>>Regulatory Open Forum
Good morning, Willard. In the U.S., disinfectants fall under the jurisdiction of both the FDA and EPA. The agencies have an MOU in place to better define there roles. Accordingly, devices that are intended for "trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals). . ." are defined as "pesticide devices", under FIFRA section 2(h),. Pesticide [More]
RE: Upcoming Chicago Chapter Webcast with Dr. Bassil Akra
From : Communities>>Regulatory Open Forum
Thank you for posting this here Annie as the webcast was excellent (as would be expected from Dr. Akra haha) - but really it was great to have this publicly available as there was nice information about the EU MDR conveyed. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------
RE: FDA DOC vs general use of consensus standard
From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation. These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following. I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]
RE: EUA Timeline
From : Communities>>Regulatory Open Forum
Yes, you will need to achieve a 510(k) clearance after the emergency use has been officially ended by the FDA as William mentions. Much of the information is the same, but the review process is intended to be expedited. If you want to continue selling the product in the United States after the emergency use, you should really submit a 510(k) now; while the virus issue may continue for a few months it will take a few months for 510(k) clearance. And if you have an EUA Approval this really is not [More]
RE: 510(k) accessories
From : Communities>>Regulatory Open Forum
Hello Shikha, This depends on whether the form, function, and operation of the medical device is affected by the change to the accessory. Without knowing the device, the accessory, or the type of change, it is hard to say, but I refer you to the FDA Guidance document for when to complete a 510(k) for an existing device. If you go through the flowchart and read the descriptors for each there is the item B.5 and then the sub-boxes 1 through 4. There is the question whether a change to accessory [More]
RE: New: Take the RAC Exams Online this Summer!
From : Communities>>Regulatory Open Forum
Annie: Thank you for sharing this news. I am curious whether the Board considers this a limited exception or a potential new normal option going forward? Scott ------------------------------ Scott Bishop Houston TX United States ------------------------------ ------------------------------------------- Original Message: Sent: 04-May-2020 08:50 From: Annie O'Brien Subject: New: Take the RAC Exams Online this Summer! The RAC board has been working hard to find solutions offering more flexibility [More]
RE: 510(k)
From : Communities>>Regulatory Open Forum
See FDA Guidance For Industry: When to submit a new 510(k) for an existing device. It will walk you through a decision tree. ------------------------------ William Coulston PMP, MS, RAC Quality & Regulatory Manager San Antonio TX United States ------------------------------
RE: EUA Timeline
From : Communities>>Regulatory Open Forum
Hello, The EUA is much faster than the 510(k) process. However, the EUA intended uses are only authorized during the state of emergency. Once the state of emergency ends so does your authorization for the EUA intended uses. The 510(k) clearance is permanent and authorizes the product with its cleared intended uses, to be put into interstate commerce. Hope that helps. ------------------------------ William Coulston PMP, MS, RAC Quality & Regulatory Manager San Antonio TX United States -------- [More]
RE: Drug Component Quality (OTC vs Combination Product)
From : Communities>>Regulatory Open Forum
I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product. The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes. Remember, FDA expects that drug products meet specific requirements. Things like [More]
510(k) accessories
From : Communities>>Regulatory Open Forum
Hello, If there is a significant change to an accessory cleared under a 510(k) of a product, are we supposed to file a significant change to the FDA for the original 510(k) for the accessory? ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------
510(k)
From : Communities>>Regulatory Open Forum
Hello , I would like to understand when can we release a new product/accessories under Letter to File for a 510(k) cleared device. ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------
RE: Upcoming Chicago Chapter Webcast with Dr. Bassil Akra
From : Communities>>Regulatory Open Forum
Hi @Britta Cyron , Thanks for your question. Let me connect with my RAPS colleagues on this to get you an answer and then I will follow-up with you directly. Best, Annie ------------------------------ Annie O'Brien Community Manager Regulatory Affairs Professional Society regex@raps.org ------------------------------
Drug Component Quality (OTC vs Combination Product)
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!
RE: Online sale of unapproved combinations of Minoxidil as topical solution
From : Communities>>Regulatory Open Forum
The only possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation. That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]
RE: Online sale of unapproved combinations of Minoxidil as topical solution
From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]
RE: EUA Transition To Clearance
From : Communities>>Regulatory Open Forum
Thank you!!! Good to know that everyone is having a wonderful interactive experience. --------------------------------- Beverly Whitaker Beaufort SC United States ---------------------------------
RE: UV Light Sterilizers
From : Communities>>Regulatory Open Forum
Hi, Willard - The Product code RHP won't show any 510(k)s because that is not a match for any regulated medical device. You can see the classification in the "Radiation Emitting Electronic Product Codes" page (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm?PCD=RHP), where it also notes that for this Product Code, there are no applicable standards for these "UV Lamp, Germicidal" products. If it were a medical device, it might fall under FDA's classification for certain [More]
RE: FDA DOC vs general use of consensus standard
From : Communities>>Regulatory Open Forum
Hello Anonymous You will be generating software documents (which is data of a sort), in accordance with ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission. I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device usability study is not required in a submission don't put it in there unless asked. Just my opinion. Biocompatibility if used, is generating test [More]
RE: UDI Requirements under an Emergency Use Authorization
From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates
RE: Online sale of unapproved combinations of Minoxidil as topical solution
From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]
RE: UDI Requirements under an Emergency Use Authorization
From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good. From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products. (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important. Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]
Online sale of unapproved combinations of Minoxidil as topical solution
From : Communities>>Regulatory Open Forum
Hello, I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website. Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice? Thanks Ankur RAC
RE: Traditional 510(k) RTA checklist
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.
RE: FDA DOC vs general use of consensus standard
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]
Draft 2020 Chinese pharmacopeia includes hundreds of new pharmaceuticals
From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted, the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]
RE: UDI Requirements under an Emergency Use Authorization
From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices. Feel free to contact me if you have any questions. Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]
RE: Sort It Out by participating in the RAPS Tagging Project
From : Communities>>Regulatory Open Forum
Thank you RAPS, what a pleasant surprise! I appreciate the opportunity to contribute to the project! Now, if only Amazon had any toilet paper in stock... ------------------------------ Jonathan Amaya-Hodges Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices Cambridge MA United States ------------------------------
RE: Sort It Out by participating in the RAPS Tagging Project
From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached. I'm happy to announce that the winner is ... @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here . ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]
Files Attached Document
RE: Sort It Out by participating in the RAPS Tagging Project
PLM v. Re-seller for CE Mark of Medical Device System
From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]
RE: Medical Device Submissions - Worldwide
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?
FDA DOC vs general use of consensus standard
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304- ANSI AAMI IEC 62304:2006/A1:2016 62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]
EUA Timeline
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Hello, Does anyone know how long FDA's EUA process takes for approval compared to a 510k. EUA seems to ask a lot of the same information that a 510k requests so not clear on what the benefits are or if it's worthwhile. I assume you will eventually have to achieve traditional market clearance at some point. Any insight would be most appreciated. Thank you.
RE: EUA Transition To Clearance
From : Communities>>Regulatory Open Forum
I have not seen anything, but during the interactive EUA process FDA were very clear that we need to continue with 510[k] preparation and offered supportive and constructive comments of where additional information would be needed. Although the EUA team are very busy, they see it as mutually beneficial, well actually in everybody's interests, to help us to a cleared status as soon as possible and the level of interactive engagement has been great. I am not convinced any general guidance would have [More]
RE: EUA Transition To Clearance
From : Communities>>Regulatory Open Forum
Hi Beverly, To find out details on EUAs go to the FDA website central for EUAs at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019. They are pumping out lots of them pretty quickly. Each type of EUA has different requirements and FDA is flexible depending on the EUA you are looking for. Timelines are not specific I just asked that question of one of my connections at the FDA today. They are giving priority to more technically [More]
RE: Topical gel Syringe change - plastic to glass
From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant
RE: Upcoming Chicago Chapter Webcast with Dr. Bassil Akra
From : Communities>>Regulatory Open Forum
Hi Annie, I knew before that I wouldn't be able to attend to the webcast, so I did not register for it. But I am very curious on Dr. Akras insights. Is it possible to view a recording of it? Thanks, Britta ------------------------------ Britta Cyron Bochum Germany ------------------------------
RE: Traditional 510(k) RTA checklist
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form? You will need it to compile the submission anyway.
RE: Cell banks for cell culture process development
From : Communities>>Regulatory Open Forum
The short answer is "yes" provided that the development cell bank was the source for the GMP bank and is comparable in terms of performance. However, the devil is in details and you need to evaluate "comparability" carefully between the development bank and the GMP bank with respect to the characterization data you plan to use for, e.g., to support GMP bank for production, etc. Two ICH guidance documents are useful to look at, Q7 Table 1 and Q5D. The US FDA generally follows ICH guidance but EMA [More]