APEC officials announced this year’s winners for the annual APEC Business Efficiency and Success Target Awards, or BEST Awards - a collection of some of the best women-led businesses in the Asia-Pacific region.

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.

Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

Finance Ministers from APEC member economies issued a joint statement reflecting the outcomes of the APEC Finance Ministers’ Meeting in Santiago, Chile, chaired by Chile’s Minister of Finance Felipe Larrain.

President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year.

The impact of corruption is far-reaching and devastating, especially for women.

Research Promoting Women’s Health to Receive $20,000 Prize

La Serena Roadmap for Women and Inclusive Growth to bolster progress

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

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]

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]

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]

From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates ) to my query. I was reminded that the waiver to good manufacturing practice and labeling requirements were included in the individual authorization letter. The person responding to my question concerning the UDI requirement provided the following: UDI is not specifically noted; however we are not enforcing UDI during the emergency. The specific authorization letter I was reviewing was for [More]

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…

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.

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies.

The company receives approval for MenQuadfi to prevent meningococcal disease.

Ajinomoto agrees partnership to manufacture leronlimab, which is currently undergoing clinical trials for the treatment of COVID-19.

Menarini adds Stemlineâs lead product, Elzonris, and its presence in the US with buyout deal.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned.

To read the whole article click on the headline

Pharmacists will not be automatically eligible for a new government life assurance scheme for healthcare workers in England who die from COVID-19 during the pandemic.

To read the whole article click on the headline

Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

To read the whole article click on the headline

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […]

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.

A new report out by Innova Market Insights has identified several new trends that are driving sports nutrition.

While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money.

With social distancing in full effect, families have not only found themselves with a lot more time together, but a lot more time in front of their screens.

The recommended daily allowance of protein may be inadequate to support maintenance of muscle in young women and eating protein from the humble potato can help to maintain muscle, according to research from McMaster University funded by the Alliance for Potato Research & Education.

As part of our follow up to our recent Biotech in Wisconsin Meetup about professional development skills, we are asking folks to fill out this poll.

Today I had the chance for a panel conversation with Geeta Vemuri from Baxter Ventures and Ed Silverman from Pharmalot blog (Wall Street Journal) at the Midwest Healthcare Venture Forum. Our general topic was how we (an entrepreneur and a corporate venture capitalist) look at bringing drugs/devices to market. Here are a couple of takeaways from our

President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states.

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]