PharmTech Talk

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

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.

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.

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Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.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

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.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

New programs and initiatives by industry examine rising healthcare costs.

The President described US drug costs as unfair and stated that prices will come down.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

New tax legislation may result in savings for biopharma companies.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

Manufacturers and trading partners struggle to meet drug tracking requirements

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.