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Drugmakers seeking approval of a product intended for use in women of reproductive age should conduct lactation studies on the drug, even in cases when the product would rarely be used in lactating women, according to a new FDA draft guidance.
Radio-frequency identification (RFID) use in the pharmaceutical industry is growing under state and federal mandates to secure the supply chain and prevent counterfeiting, but technology limitations and security weaknesses may slow full implementation, according to an ABI Research study, "The RFID Life Sciences Market," which looks at the driving forces behind adoption and RFID's benefits.
Manufacturers should begin nonclinical testing of all new investigational drugs to determine what, if any, impact they have on a patient's immune response, according to a new FDA draft guidance released under the auspices of the International Conference on Harmonisation.
The FDA has published a question-and-answer guidance containing recommendations for drugmakers to convert OTC drug monograph labeling to the OTC “Drug Facts” format.
The FDA released a draft guidance Jan. 25 containing recommendations on nonclinical safety evaluations to support the clinical study and approval of fixed-dose combination products, co-packaged products and adjunctive therapies.
The Good Automated Manufacturing Practice (GAMP) Forum announced it will release a GAMP good practice guide Feb. 18 that will provide comprehensive direction on meeting current 21 CFR Part 11 expectations for compliant erecords and esignatures, including requirements for record integrity, security and availability throughout the required retention period.
The Centers for Medicare & Medicaid Services (CMS) released a Draft Decision Memo Feb. 3 proposing new billing codes for power wheelchairs and scooters, as well as coverage criteria for mobility assistive equipment (MAE) that would rely on clinical guidance for evaluating whether a beneficiary needs a device to assist with mobility and, if so, what type of device is needed.
Rival devicemakers Johnson & Johnson (J&J) and Boston Scientific are looking to expand their market share for drug-eluting stents in Japan — the second-largest interventional cardiology market in the world after the U.S. — and said they will concentrate on international market expansion and stent pricing in 2005.
The pharmaceutical industry has been slow to respond to the FDA’s call to implement the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), FDA officials said at a Feb. 1 public meeting at agency headquarters in Rockville, Md.