China’s Five-Year Plan for Biotech Making it Increasingly Attractive for Global Pharma
The China pharmaceutical industry is taking a multi-pronged approach to becoming a dominant player in Asia. Maybe even the world.
FDA Advancements Act Passes Committee, Sets Stage for Fall Reauthorization Passage
The FDA Safety and Landmark Advancements (FDASLA) Act has passed a key committee, with 25 out of some 30 amendments passing. Generics and baby formula crisis got most of the attention.
CPA Questions FDA Commissioner on Faulty Data on Indian Generic Drugs
WASHINGTON — The Coalition for a Prosperous America (CPA) today sent a letter to Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA), over the agency’s controversial decision to allow the continued sale of generic drugs from India despite faulty data and a lack of proof of therapeutic equivalence. FDA did not prohibit…
FDA’s Updated Drug Shortage List Loaded with Critical Medicines
The Food and Drug Administration recently updated its drug shortage list. More than half of the updates include drugs on the essential medicines list.
Senate Puts FDA Re-authorization Deal in Jeopardy Over Infant Formula Crisis
Senator Burr warned the FDA that until the Senate is okay with their response to the infant formula crisis, and present a plan to prevent it in the future, the Generic Drug User Fee Authorization bill might be put on hold.
CPA Urges President Biden to Address Decades of Failure by the FDA
WASHINGTON — The Coalition for a Prosperous America (CPA) urged President Joe Biden to address the decades of dereliction of duty by the Food and Drug Administration (FDA) to ensure our nation has a safe, affordable, and readily accessible supply of generic and other essential medicines. Earlier this year, CPA launched Americans for Safe Drugs,…
CPA Letters to Leaders of House, Senate Health Care Committees Regarding FDA’s Failure on Essential Generic Medicines, Shortages
CPA sent the following letters to the Chairs and Ranking Members of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee regarding the Food and Drug Administration’s (FDA) lack of action on addressing shortages of essential and lifesaving products, including critical generic medicines and baby formula, and the agency’s…
CPA Letter to President Biden Regarding Essential Generic Medicines, Excessive Offshoring, and Failure of Safety and Efficacy
CPA sent the following letter to President Joe Biden requesting that his administration take action to address the failures of the Food and Drug Administration (FDA) to ensure Americans have access to safe, affordable, and reliable medicine. Dear President Biden: We write to you regarding the crisis facing our nation as a result of decades…
Pharma and Trade Deals Top of Mind in China Commission Hearing
The U.S. China Economic and Security Review Commission discussed the tight-linked China-India pharmaceutical supply chain, and tossed aside the notion that sweeping trade deals with India and the region are good ideas.
FDA Funding Bill Heads to Final Committee, With One Major Stumbling Block
The Health subcommittee of the House Energy and Commerce Committee have moved the FDA user-fee reauthorization bill to final committee. Chairwoman Eshoo says it is on track for September approval.