FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acella Pharmaceuticals, Alpharetta, GA, (8/14): FDA inspected the firm in January and found significant GMP violations for finished drugs. For example, Acella failed to establish laboratory controls that
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Innate Pharma’s Lumoxiti (moxetumomab pasudotox-tdfk), indicated for treating adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Adverse Experience Reporting For Licensed Biological Products; and General Records—21 CFR Part 600” (OMB Control Number 0910-0308). The collection supports FDA-issued adverse experience reporting requirements in part 600 (21 CFR part 600) to enable
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. FDA says patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support regulatory and healthcare
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB. They are: * Accreditation Scheme for Conformity Assessment Pilot Program * General Administrative Practice and Procedures * Records and Reports Concerning Experience With Approved New Animal Drugs * Adverse Event Program for Medical Devices (Medical Product Safety
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Quidel has entered into definitive agreements to acquire for $400 million the Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers from Alere Inc. The products are being divested in order to obtain antitrust approvals required for Abbott’s
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 joint meeting of its Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Panel members are scheduled to discuss the efficacy, safety, and benefit-risk profile of an Alkermes NDA for olanzapine and samidorphan oral tablets, indicated for
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss the development, authorization and licensure of Covid-19 vaccines. The agency says no specific application will be discussed at the meeting. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. The document provides recommendations on clinical trial designs for drugs and biological products that are intended to support product labeling describing the antitumor activity in patients with central nervous
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 Patient Engagement Advisory Committee meeting. Panel members are scheduled to discuss artificial intelligence and machine learning in medical devices, particularly the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that
FDA Policy/General
[Report by Jim Dickinson and David McFarland] FDA commissioner Stephen Hahn’s controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 at an 8/23 White House press conference has touched off a wider examination of those advising (or directing?) him with his communications efforts. The 8/23
Drugs
Dusa Pharmaceuticals, a Sun Pharmaceutical subsidiary, has agreed to pay $20.75 million to the U.S. to resolve allegations raised in a whistleblower lawsuit that it caused doctors to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an administration process for the
FDA Policy/General
Federal Register notice: FDA has announced a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss required postmarketing studies that evaluated the effect of Purdue Pharma’s reformulation of Oxycontin (oxycodone
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Banco Vida Corp., San Juan, Puerto Rico (8/12): FDA inspected the firm 9/2019 and cited significant deviations from current good manufacturing practice and current good tissue practice
FDA Policy/General
FDA has issued a priority review voucher to Genentech for gaining approval of a rare pediatric disease product application — Evrysdi (risdiplam), indicated for treating patients two months of age and older with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. To view the
FDA Policy/General
Federal Register notice: FDA has issued a final rule to remove the specified test for detecting the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive since
FDA Policy/General
Medeon Biodesign has agreed to sell to Tokyo-based Terumo Corp. its large bore vascular closure system. The transaction includes an up-front payment of $20 million and future milestone payments. The acquired device, a suture-mediated closure device with two braids, is intended to target percutaneous large bore procedures
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 7/7 Federal Register that discussed version 1.7 of the Clinical Data Interchange Standards Consortium for Study Data Tabulation Model Implementation Guide 3.3. The document provided the incorrect dates for these electronic study data standards. To
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dompe Farmaceutici’s Oxervate (cenegermin-bkbj), indicated for treating neurotrophic keratitis. The regulatory review period is 1,484 days, which includes 1,240 days during the testing phase and 244 days during the approval phase.
FDA Policy/General
Federal Register notice: FDA is announcing an 8/28 virtual public meeting entitled “Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program — Summer 2020.” The meeting will discuss developing standard core sets of clinical outcome assessments (COAs) as part of an FDA pilot grant program,
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel, which will discuss a TransMedics PMA for its Organ Care System (OCS) — Heart. The portable ex-vivo organ perfusion and monitoring system is indicated for the resuscitation, preservation, and