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Human Drugs

Trump Changing Drug Price Plan

The Hill reports the Trump administration is proposing to lower some drug prices by ensuring that prices in this country are lower than comparable pri...

Human Drugs

FDA Making Less Use of Advisory Committees: Analysis

Eye on FDA notes a reduction in the number of drug-related advisory committee meetings this year and whether this can be seen as less transparency in ...

Low Number of Drug Recalls in Third Quarter: Stericycle

The Stericycle Expert Solutions third quarter recall index shows a lower number of prescription drug recalls and a very high number of medical device ...

Human Drugs

Braeburn Says Brixadi Can Be Marketed 12/1/20

Braeburn says its Brixadi treatment for opioid use disorder is available to be marketed 12/1/20 after FDA revoked the orphan drug designation for Indi...

Medical Devices

Export Certificate Review Process Guidance

FDA issues a guidance explaining the process to seek review of a Certificate to Foreign Government denial.

FDA General

Supreme Court to Consider Disgorgement Legality

Ropes & Gray says the Supreme Court will consider whether the SEC has the legal authority to seek disgorgement as an enforcement tool in a case that c...

Human Drugs

GSK Seeking Nucala Approval in Hypereosinophilic Syndrome

GlaxoSmithKline says it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome based on just-announc...

Federal Register

Workshop on Clinical Outcome Assessments

Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision mak...

Medical Devices

FDA Starts TMD/TMJ Web Pages

FDA launches temporomandibular disorders Web pages.

Federal Register

Info Collection on Combo Product Jurisdiction

Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review of P...