FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications” (OMB Control Number 0910-0796). The collection supports studies relating to the regulation and communications related to tobacco products, including qualitative research through focus
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Cardiovascular and Renal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/2022. To view the notice, click here.
Drugs
A 2/10-2/20 FDA inspection at Panacea Biotec, New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 Warning Letter says specific violations were: * failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans,
Drugs
A 2/6-2/14/19 FDA inspection at Intrathecal Compounding Specialist, Scott, LA, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk. A 9/15 Warning Letter gives examples of the firm preparing, packing, or holding drug products intended or
Devices
FDA has published a guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, with recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The document says the agency is issuing it to help ensure that a patient receives and understands
FDA Policy/General
Federal Register notice: FDA has announced the availability of a final guidance entitled Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. The document describes studies and information that the agency recommends be used when submitting 510(k)s for blood glucose monitoring systems that are for prescription
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Assessing Covid–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid–19 Prevention or Treatment. The document describes an example with a set of common Covid–19-related symptoms
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “ANDA Submissions — Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” The document is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. To view the notice, click here.
Drugs
FDA has announced a 10/13 virtual public meeting on Patient-Focused Drug Development (PFDD) for Systemic Sclerosis to obtain patients’ perspectives on disease impact on daily life and treatment approaches. PFDD is FDA’s systematic approach to “help ensure that patients’ experiences, perspectives, needs, and priorities are captured and
Biologics
FDA commissioner Stephen Hahn says agency career scientists will follow the guidance on the evaluation of Covid-19 vaccines that President Donald Trump has threatened to overrule. Speaking 9/29 at the Financial Times U.S. Pharma and Biotech Summit, Hahn said his staff will assess all vaccine applications against
Devices
FDA has published a guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, with recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The document says the agency is issuing it to help ensure that a patient receives and understands
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Intrathecal Compounding Specialist, Scott, LA (9/15): FDA inspected the firm in February and found serious deficiencies in the firm’s practices for producing sterile drug products. For example,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The document describes recommended procedures to obtain a National Drug Code
Biologics
FDA has placed a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its Cellectra 2000 delivery device to be used in the trial. The partial hold is not due to the occurrence of any adverse events related to
Drugs
FDA has issued a guidance entitled ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs. The document is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. It also provides recommendations on the timing and content of amendments
FDA Policy/General
Federal Register notice: FDA has announced an 11/6 Peripheral and Central Nervous System Drugs Advisory Committee. Panel members are scheduled to review a Biogen BLA for aducanumab solution for intravenous infusion for treating Alzheimer’s disease. To view the notice, click here.
Drugs
FDA has released a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. The document is intended to assist ANDA applicants in responding to complete response letters (CRLs) from FDA. It provides information and recommendations regarding potential courses of action for an ANDA
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 7/21 Federal Register announcing the withdrawal of approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. Two ANDAs from Kadmon Pharmaceuticals (ribavirin capsules and tablets) are now not being withdrawn because the company timely informed
FDA Policy/General
Federal Register notice: FDA has issued a final rule to allow importation of certain prescription drugs from Canada. Under the rule, states and indian tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the agency for review and authorization. The rule contains all requirements
Drugs
FDA has approved a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas
Drugs
FDA has posted an International Council for Harmonization (ICH) draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk — Questions and Answers. The draft document addresses common questions that have arisen since the ICH M7 guideline was implemented based on recommendations
FDA Policy/General
CorMatrix Cardiovascular has begun a feasibility study involving its tissue-engineered regenerative CorMatrix ECM Tricuspid Valve. The study at eight sites in the U.S. is intended to demonstrate proof of principle and initial clinical safety of the valve for the surgical management of tricuspid valve disease not amenable to