FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Conformis Inc. Billerica, MA (12/10): FDA inspected the company in November and cited quality system deficiencies with its Class 2 sterile orthopedic implants. For example, Conformis failed to
FDA Policy/General
Federal Register notice: FDA is seeking input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations in establishing strategic priorities for its Office of Minority Health and Health Equity. The input is intended to help the agency ensure that important health concerns are carefully considered
FDA Policy/General
FDA has published a guidance, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, indicating that for ENDS products without agency authorization, FDA intends to prioritize enforcement against: * any flavored, cartridge-based ENDS product (other than tobacco- or menthol-flavored ENDS
FDA Policy/General
Federal Register notice: FDA is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. The rule is intended to improve and make more efficient the agency’s premarket submission program
FDA Policy/General
Federal Register: FDA has made available a draft guidance entitled “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.” The document addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and BLAs are expected to be submitted on
FDA Policy/General
Federal Register notice: FDA has issued a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation. Repealing the irradiation regulation will mean that over-the-counter drug products that are generally recognized as safe and effective
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to serve on the committee. A nominee may either be self-nominated
FDA Policy/General
The Senate 12/12 confirmed Stephen Hahn as the next FDA commissioner on a floor vote of 72-18. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer Institute director.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact (brivaracetam) oral solution and separately for an injectable formulation. The oral solution is indicated for adjunctive therapy in treating partial-onset seizures in patients 16 years of age and older with epilepsy, whereas the
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Alkermes print ad for Vivitrol (naltrexone for extended-release injectable suspension) for intramuscular use is false and misleading because it omits important risk information associated with using the drug. A 12/2 Warning Letter says the violation “is concerning from
FDA Policy/General
A recent DC federal court decision in a Centers for Medicare and Medicaid Services (CMS) case could be followed to a conclusion that courts may see FDA Warning Letters as final agency action. Attorney Michelle Yeary (Dechert) says in an online Drug and Device Law post that the case involved
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Rempex Pharmaceuticals’ Vabomere (vaborbactam and meropenem), indicated for treating patients 18 years and older with complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria. The regulatory review period has been determined to be
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0605). FDA’s regulations specify the criteria and procedures for requesting MUMS designation as well as
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. OHM Pharma, Mineral Wells, TX (11/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, OHM failed to maintain the buildings
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document addresses the recommended patient attributes for enrollment, efficacy assessments, safety assessments, and additional considerations under development programs and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Magnetic Resonance (MR) Coil — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s Safety and Performance Based Pathway. Under the framework, if a legally
FDA Policy/General
Joint Panel to Review Nektar Back Pain Drug Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting to discuss a Nektar Therapeutics drug. 12/06/2019 Review Period for Biomarin’s Palynziq Federal
FDA Policy/General
Otsuka Pharmaceutical Co. has agreed to acquire Neurovance, a privately held clinical stage pharmaceutical company focused on attention-deficit hyperactivity disorder and related disorders. Under the terms of the agreement, Otsuka will provide an estimated $100 million in upfront payments at closing, up to $150 million in additional payments contingent
FDA Policy/General
Federal Register notice: FDA has announced a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting. The committees will discuss a Nektar Therapeutics NDA for oxycodegol, a new molecular entity full mu-opioid receptor agonist for managing chronic low
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz), indicated to reduce blood phenylalanine concentrations in certain adult patients with phenylketonuria. The regulatory review period is 3,803 days, which includes 3,474 days that occurred during the
FDA Policy/General
Federal Register notice: FDA has announced a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting. During the morning session, the committees will discuss an Esteve Pharmaceuticals NDA for a combination tramadol 44 mg and celecoxib 56 mg
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). FDA regulations in 21 CFR Part 111 establish minimum GMP requirements pertaining to the