White men who have sex with men Hispanic men who have sex with men Black men who have sex with men Source: Milan lost his partner during the height of the epidemic, and has himself lived with HIV for 35 years. He says that stigma keeps people from getting tested, accessing health care, accessing support, and from disclosing their status to their sexual partners. The reluctance to get tested and treated has real consequences. HIV is disproportionately spread by those who don’t know they’re positive. When one partner is HIV positive and the other is negative, PreP has the potential to play a crucial role in reducing stigma, supporters say, by helping to redistribute the responsibility of prevention between both positive and negative individuals. Similar to what can happen to women on birth control, Villalobos says there is “slut shaming” of those on PrEP based on a fear that it will lead to an increase in condomless sex and a higher number of sexual partners. It is funny to me that you walking biohazards never learn your lesson and yet here you are taking more loads. I’m not a biohazard and it wasn’t my boyfriend.
Recent FDA Draft Guidance on Repackaging Raises Concerns About Beyond Use Dates (BUDs)
The 40 types of changes are divided into six categories: Examples from the list of qualifying changes include: The guidance includes a description of the requirements for an annual report and the governing regulations. FDA is asking that public comments and suggestions regarding its new draft guidance be submitted within 90 days of its June 25 publication date in the Federal Register.
By Global Compliance Seminar (LinkedIn; Twitter) FDA Guidance: Medical Device Shelf Life Determination INTRODUCTION. The potential benefit from the use of a medical device ranges from relieving minor irritations to correcting life threatening conditions.
Potassium iodide is a salt, similar to table salt. Its chemical symbol is KI. It is routinely added to table salt to make it “iodized. What is the role of potassium iodide in radiological emergency preparedness? Potassium iodide is a special kind of protective measure in that it offers very specialized protection. Potassium iodide protects the thyroid gland against internal uptake of radioiodines that may be released in the unlikely event of a nuclear reactor accident.
The purpose of radiological emergency preparedness is to protect people from the effects of radiation exposure after an accident at a nuclear power plant. Evacuation is the most effective protective measure in the event of a radiological emergency because it protects the whole body including the thyroid gland and other organs from all radionuclides and all exposure pathways. Administering KI can be a reasonable, prudent, and inexpensive supplement to in-place sheltering and evacuation.
What is the benefit of taking potassium iodide during a radiological accident? When potassium iodide is ingested, it is taken up by the thyroid gland. In the proper dosage, and taken at the appropriate time, it will effectively saturate the thyroid gland in such a way that inhaled or ingested radioactive iodines will not be accumulated in the thyroid gland. The risk of thyroid effects is reduced.
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations.
The CGMPs were purposely written broadly to allow for such unique differences. Absence of an Expiration Date The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by
44 This guidance and any resulting expiration date extensions authorized by FDA do not apply to 45 doxycycline available commercially or otherwise held for any other non-emergency purpose.
Feb 15, 5 min read Now that the 3D printing of medical devices has become a promising reality, the U. With so many disruptive medical technologies coming on the market, manufacturers need this guidance to help them navigate faster and more easily the time consuming process of FDA approval. So what is new? Here is some of the highlights of the guidance.
The final guidance expands upon the recommendations for file format conversions in the draft guidance, noting that file critical attributes and performance criteria should be verified as part of the software workflow validation to ensure expected performance, particularly for Patient-Matched Devices PMDs. One of the most notable changes in the final guidance is the inclusion of additional issues in the section regarding PMD Designs. A concern expressed by the FDA is the passage of time, as explained: The guidance recommends that manufacturers of PMDs follow considerations on maintaining data integrity throughout file conversions.
The final guidance also provides a description of the type of information FDA recommends in a premarket submission of a device made using additive manufacturing, including what FDA expects from a device description, mechanical testing, dimensional measurements, material characterization, removing manufacturing material residues, sterilization and biocompatibility.
All this information contained in the guidance will prove useful for manufacturers planning product submissions for FDA approval, as it outlines clearly what to include in the premarket submission for a device that uses additive manufacturing. As the technology continues to grow, it can be anticipated that the FDA will become more and more involved in the process. Mary brings over a decade of medical device industry and clinical experience and holds a M.
In her spare time, she enjoys traveling abroad and is an avid runner and cyclist.
What the FDA Guidance on 3D Printed Devices Means for Medical Manufacturers
Scott Gavura on May 10, Shares Consider this scenario: You use the following remedies occasionally: Excedrin for the rare migraine Arnica 30CH for bumps and bruises Echinacea capsules, when you feel a cold coming on Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them?
In the previous draft guidance on expiration dating issued in May , the FDA had proposed to set the expiration date for nonsterile, unit-dose repackaged drugs to one year, which was also aligned with USP standards at the time for beyond use dating for unit-dose repackaging by dispensers.
Medical Gas Expiration Dates Published: June 15, Many medical gas manufacturers including majors have applied expiration date stickers to their cylinders for years. To summarize, as of March , we were required to use expiration dates AND we were required to conduct a stability study to justify the expiration date. Also in the draft guidance, the FDA said the following about stability studies: The Agency recommends that the testing program take into account the compatibility of the valve assembly, the acceptability of the valve packing and the valve seal used, the type of cylinder and any other factor that can have an effect on the stability of the medical gas.
Each medical gas would be tested for stability in the exact container closure system that it is marketed in, such as steel high-pressure cylinders, aluminum high-pressure cylinders and cryogenic containers. They know that most medical gases are stable elements. Usually this enforcement discretion is reasonable and in the best interest of industry. We learn by experience sometimes painful what the FDA enforces. The drug product does not bear an expiration date determined by appropriate stability testing [21 CFR
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
Inadequate investigation of unexplained discrepancies among batches. The report notes that Biocon did not properly investigate the presence of visible particulate material that had been observed in an injectable drug since August The drug in question continues to be sold in Uruguay, Russia, and the Dominican Republic.
FDA sometimes receives questions from consumers and industry, asking about shelf life and expiration dates for cosmetics. Here are answers to some common questions on this subject.
Have the Labeling Requirements been Met? No pre-approval of label is required by FDA for products under its jurisdiction. It is the responsibility of the manufacturer or importer of a food to comply with current food labeling regulations. Pre-approval of label by USDA is required for products under its jurisdiction; e. Food service products ; e. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines Detailed regulations for labeling various alcoholic beverages are found at 27 CFR parts 4, 5, 7, 13 and 16 The Bureau’s Labeling Resources are available on the web.
Product Coding Not the same as labeling even though it is part of the packaging; coding is intended to help identify the source of the food item. For example, poultry package must contain a date and lot number; 9 CFR The firms decide the level of detail. For example, do they want to be able to identify the time of day of processing, or just the shift during which the food was processed?
More detail allows the firm to"pin point” when a product was processed, but each level of detail perhaps adds cost to the business operation.
FDA streamlines CGMP compliance for combination products
We are working with a client who has not placed expiration dates on their study medication. We know this isn’t required by regulation, but this is the first time I have worked with an experimental product that does not have expiration dates for their lots. How does FDA handle this? Certainly patients can’t continue taking medication that hasn’t been demonstrated to be stable- i.
ITG SUBJECT: EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS. BACKGROUND. Publishing of 21 CFR Part – Current Good Manufacturing Practice for Finished Pharmaceuticals.
Food and Drug Administration FDA published its final rule implementing current good manufacturing practice CGMP requirements for combination products, which will take effect on July 22, The relevant CGMP requirements are still in effect for each constituent part of a combination product e. FDA, however, noted that because of the overlap between drug CGMPs and device Quality System QS regulations, firms are currently required to comply with redundant standards, which is unnecessary and inefficient in certain situations, such as with constituent parts of single-entity and co-packaged combination products, which are defined under 21 C.
These parts are not individually packaged and are not necessarily manufactured under a separate manufacturing system. Accordingly, the new rule develops practical applications for CGMPs for those types of combination products. The general approach of the rule is ” 1 [t]o demonstrate compliance with the specifics of all CGMP regulations applicable to each of the constituent parts included in the combination product or 2 to demonstrate compliance with the specifics of the drug CGMPs or the QS regulation, rather than both In other words, if a firm chooses to follow drug CGMPs, they would be required to still comply with certain QS regulations that are absent from drug CGMPs, such as management responsibility, design controls and purchasing controls.