FDA Related News

Human Drugs

Almirall Paying $3.5 Million on Kickback Charges

The Justice Department says Almirall is settling a whistleblower case alleging improper kickbacks to doctors for $3.5 million.

Medical Devices

Terumu Recalls Catheter Placement Devices

Terumo Medical recalls its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip t...

Human Drugs

Epizyme Tazemetostat NDA Filed for Epithelioid Sarcoma

Epizyme submits an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not ...

Human Drugs

Pros and Cons of Continuous Manufacturing Guidance

Support and caution is expressed by industry commenters on an FDA draft guidance on continuous manufacturing.

Human Drugs

Bioavailability Studies Guidance Comments

Two stakeholders submit comments and suggestions for an FDA draft guidance on bioavailability studies in NDAs or INDs.

Federal Register

Correction on OTC Maximal Usage Trials Docket

Federal Register notice correction: FDA corrects the docket number on a 5/10 notice entitled Maximal Usage Trials for Topically Applied Active Ingredi...

Federal Register

Info Collection on OTC Drug Labeling

Federal Register notice: FDA submits to OMB an information collection extension entitled Labeling of Nonprescription Human Drug Products Marketed With...

Human Drugs

Heritage Recalls 2 Drugs Over Microbial Growth

Heritage Pharmaceuticals recalls one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, U...

Human Drugs

Stakeholders Speak on Insulin Supply

Stakeholders representing various interests tell FDA their positions on biosimilar and interchangeable insulins.

DoJ Reiterates Compliance Evaluation Factors

Two attorneys writing for Washington Legal Foundation say a new Justice Department guidance for its prosecutors reiterates the importance of corporate...