FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. These clearances are based on short-term (30 day) patient follow up. By Jeffrey K. Shapiro & Allyson B.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

IT 69

IT Medical Patient-Centered Provider 69