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.

Choose NJ’s RFP Watch

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)

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

U.S. Senate’s ‘Right to Try’ Bill Could Face Slower Action in House

Washington, DC, August 15, 2017Roll Call reports that a U.S. Senate-passed “right to try” bill that is intended to help dying patients access experimental drugs, which have yet to receive Food and Drug Administration (FDA), likely will face lengthier deliberations in the U.S. House of Representatives.

While the Senate fast-tracked the bill on August 3, the House will likely subject it to a hearing and markup before bringing it up to a vote, according to congressional aides and a lobbyist.

The bill would reduce some of the paperwork involved in getting access to experimental treatments, and would offer protections to the drug companies who choose to make drugs available outside of a clinical trial. Continue reading

STAT: FDA Puts New Restrictions on Hiring of Foreign Scientists, Documents Show

Washington, DC, August 14, 2017 — Erin Mershon reports on STAT that the Food and Drug Administration (FDA) is implementing a new hiring protocol that could make it significantly harder for foreign scientists to find jobs and research opportunities at the agency, according to interviews and newly obtained documents.

Mershon reports that the FDA recently began directing hiring managers not to extend any employment offers — including for fellowship and contractor positions — to any individual who has not lived in the U.S. for at least three of the five previous years, according to briefing materials shared with STAT that have been presented to some agency employees. Continue reading

Trump Will Sign FDA User Fee Reauthorization Bill, Ending Threat of Agency Layoffs; Industry Praises Move

Washington, DC, August 8, 2017 — Zachary Brennan reported on Endpoints News that President Donald J. Trump will sign bipartisan legislation, passed by the U.S. Senate on August 3, that reauthorize the Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.

A spokesman for President Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”

The Senate’s passage of the House bill by a vote of 94-1 — Bernie Sanders (D-VT) was the only vote against — came more than two years after negotiations on the reauthorization began. Continue reading

U.S. Senate Passes Bill to Improve Cancer Drugs for Children

Washington, DC, August 7, 2017 — Ledyard King reports in USA Today that, until now, drug companies have been free to decide whether to pursue treatments for pediatric cancers as part of their work on adult cancers.

They won’t have much choice going forward.

The Senate on August 3 overwhelmingly passed legislation requiring the pharmaceutical industry to expend more resources on treatment for childhood cancers. Continue reading

U.S. Senate Passes ‘Right to Try’ Bill to Help Terminally Ill Patients Access Experimental Drugs

Washington, DC, August 3, 2017 — Laurie McGinley reports in The Washington Post that the United States Senate today passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the Food and Drug Administration.

The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states.

The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. Continue reading