Who We Are

The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

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Choose New Jersey’s RFP Watch provides up-to-date information on business opportunities throughout the Garden State at a cost that is affordable for all companies – with a place of business in New Jersey – large and small.

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Food and Drug Administration (FDA)

Medical Innovation: FDA OKs Pill with Sensor that Digitally Tracks If Patients Have Ingested Medication

Washington, DC, November 28, 2017 — The U.S. Food and Drug Administration (FDA) on November 13 approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Continue reading

FDA Announces Comprehensive Regenerative Medicine Policy Framework

Washington, DC, November 20, 2017 — The U.S. Food and Drug Administration (FDA) on November 16 announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. Continue reading

FDA vs. Pentagon: U.S. House Passes Fix to Defense Bill’s Drug Approval Provision

Washington, DC, November 17, 2017 — Rebecca Kheel reports in The Hill that the U.S. House on Wednesday, November 15 passed by voice vote a bill to speed up Food and Drug Administration (FDA) approval of medical devices and drugs to be used on the battlefield.

The bill is meant to address a controversial provision of the annual defense policy bill passed by the House on Tuesday that would allow the Pentagon to sign off on unapproved devices and drugs.

“Our men and women in uniform have put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield,” Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said on the House floor Wednesday. “We found a good balance with our friends on the Armed Services Committee, and in working with the FDA and the leadership of the Pentagon.” Continue reading

Controversy Erupts Over Congressional Plan to Let Pentagon Bypass FDA and OK Unapproved Drugs for Battlefield Use

Washington, DC, November 10, 2017 — Should the Pentagon be allowed to authorize the use of unapproved drugs and medical devices on an emergency basis for combat soldiers?

That question, Laurie McGinley reports in The Washington Post, has sparked a furious battle this week among some of Washington’s biggest power players, with the Defense Department and its congressional advocates on one side and the Food and Drug Administration (FDA) and the health committees on the other.

The Capitol Hill clash was set off by a provision in the annual defense authorization bill. Continue reading

FDA Commissioner Says His Agency — Not Defense Department — Should Control Drug and Medical Device Approvals

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, November 8, 2017 — Rachel Roubein reports in The Hill that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., said the agency should retain control over medical device and drug approvals after a provision in the defense policy bill would give this power to the Defense Department for soldiers.

Speaking a Tuesday event on opioid prevention sponsored by The Hill and the Pharmaceutical Care Management Association. Gottlieb pointed to an alternative proposal he supports that, he said, would accelerate drug and device approvals at the FDA for the battlefield. Continue reading

Gov. Christie, Pharma Executives and Federal Leaders Discuss Public-Private Partnership to Address Opioid Epidemic

Governor Chris Christie

Trenton, NJ, September 19, 2017 — Governor Chris Christie, chairman of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, yesterday joined Kellyanne Conway, Counselor to the President, and Former U.S. Rep. Patrick Kennedy, a commission member, in a roundtable at the War Memorial with leaders of the pharmaceutical industry, the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) to advance a public-private partnership that can address America’s epidemic of addiction.

Governor Christie said, “The public and private sectors must join together to address this public health crisis and act quickly to stop an epidemic delivering a death toll equivalent to America enduring another 9-11 attack every two and a half weeks.” Continue reading

FDA Commissioner Vows Modernization to Keep Up with Biotech Advances

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, September 11, 2017 — Michelle Cortez reports on Bloomberg that a week after its landmark approval of the first treatment that works by genetically altering a patient’s cells, the Food and Drug Administration (FDA) vowed to modernize to keep up with the fast-moving field of biotechnology research.

FDA Commissioner Scott Gottlieb, M.D., on September 7 said, “We are at a point in the history of medicine that is similar to other great inflections in science where fundamental principles of science and medicine became firmly established as part of a leap in public health.” Continue reading

FDA Approves First Gene Therapy to U.S.; Commissioner Gottlieb Says ‘A New Frontier in Medical Innovation’

Washington, DC, September 1, 2017 — The Food and Drug Administration (FDA) issued a historic action on August 30 making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

FDA Commissioner Scott Gottlieb, M.D., said, “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer.” Continue reading

FDA Signs Agreement with European Medicines Agency on Mutual Recognition of Manufacturing Site Inspection

London, August 28, 2017 — The European Commission (EC), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on August 23 announced they have signed a new confidentiality commitment that allows the U.S. regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators.

This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Continue reading

Trump Signs FDA User Fee Agreement into Law; PhRMA and BIO Applaud the Move

Washington, DC, August 21, 2017 — President Donald J. Trump on Friday signed into law a funding package for the Food and Drug Administration (FDA) that also takes steps to lower drug prices.

The FDA Reauthorization Act (FDARA) of 2017 reauthorizes a program in which drug and medical device makers pay the FDA a fee for every new product application.  The agency uses those funds to hire more people and speed up approvals.

The user fee program must be reauthorized every five years. The current program expires at the end of September, and if it hadn’t been signed into law before then, the agency would have had to lay off workers. Continue reading