Recent Food and Drug Administration regulations affecting small businesses

FDA determines REVIA (naltrexone hydrochloride) 50mg tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory standards.

The FDA seeks public comment on information collection requirements for orphan drugs; the 60-day comment period begins with this Federal Register notice.

FDA determines the regulatory review period for UNLOXCYT patent extension eligibility under patent term extension law for human biological products.

FDA requests 60-day public comment period on information collection requirements for its prescription drug importation regulation under the Paperwork Reduction Act.

Fagron Compounding Services recalls 16,130 bags of vancomycin HCI and four other sterile products nationwide due to failed sterility assurance and potential port detachment risks.

FDA holds public meeting on expanding nonprescription drug access and requests stakeholder comments; no specific deadline or financial impact stated for small businesses.

FDA seeks public comments on financial transparency and efficiency of prescription drug, biosimilar, and generic drug user fee programs at a public meeting.

FDA draft guidance recommends next-generation sequencing methods for nonclinical safety assessment of investigational human genome editing products in gene therapy.

MEI YU CHENG DA TRADING INC recalls 29 cases of DADI NONGFU dried salt chili vegetables distributed in NY, PA, and FL due to banned cyclamate sweetener in a Class III recall.

Beckman Coulter recalls 3 boxes of MicroScan Neg Multidrug Resistant MIC test panels distributed to Poland due to manufacturing defects that may cause incorrect in vitro diagnostic results.

Spacelabs Healthcare recalls 1,790 multi-parameter command modules (Model 91496) due to circuit board defects that may cause inaccurate cardiac output measurements and delayed patient care.

Molded Products Inc. voluntarily recalls 26,900 units of MPC-130 See Luer Cap Set nationwide due to threaded sleeve detachment risk, classified as Class II medical device recall.

Brahms GmbH recalls Class II diagnostic test catalog 859075N due to out-of-range quality control values that may produce falsely elevated results if not properly troubleshot per instructions.

Teva Pharmaceuticals recalls 8,376 packages of Isotretinoin Capsules due to superpotent and subpotent batches in Florida, Ohio, Puerto Rico, and Mississippi.

Teva Pharmaceuticals USA recalls 62,136 cartons of Clonidine Transdermal System and two other products due to unapproved raw material use; Class II recall distributed within the U.S.