Jill Wechsler

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

Leaders of the two parties are open to challenging the status quo on drug costs and spending.

A new proposal aims to reduce reimbursement for medicines administered to seniors under the Part B benefit to an amount pegged to the average price paid in foreign industrial nations.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

CDER director plans to start implementation of new review practices by the end of 2018.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

More than 120 healthcare organizations plan to bring competition to generic drug market.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.

More consistent and reliable production processes are critical for advancing innovative treatments.

Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Legislators have requested that FDA do more to prevent drug shortages.

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

FDA and Congress seek to limit the production and distribution of pain medicines.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.