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Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and I...[ Price : $8.95]
FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tub...[ Price : $8.95]
FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in...[ Price : $8.95]
FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.[ Price : $8.95]
A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded...[ Price : $8.95]
Mintz attorney Joanna Hawana explains FDAs position of regulating cannabis-derived products as shown in recent public announcement...[ Price : $8.95]
Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its ...[ Price : $8.95]
FDA orders a fertility clinic in San Juan, Puerto Rico, to cease manufacturing due to significant violations of agency regulations...